IP Library Granted Patent US 12,674,808
Granted Patent B2
US 12,674,808 · App. 17/757,379 · Granted Jul 7, 2026

Diagnostic analyzers and quality control methods

Inventor: Muhammad Ahmed (Yonkers, NY)
Assignee: Siemens Healthcare Diagnostics Inc.
G01N35/00693G01N35/00623G01N35/1011
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Quick Facts
Patent No.
US 12,674,808
App. No.
17/757,379
Filed
Jun 15, 2022
Granted
Jul 7, 2026
Kind
B2
Art Unit
2857
USPC
702/94
Abstract

A quality control method for a diagnostic analyzer includes performing a quality control test or a plurality of specimen tests; determining, with a controller, that a result of the quality control test or a plurality of specimen test results is outside of a threshold; monitoring one or more mechanical devices of the diagnostic analyzer with the controller; receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices; and initiating a calibration procedure in response to the result of the quality control test or the plurality of specimen test results being outside of the threshold and receiving the error code. Other apparatus and methods are disclosed.

Claims (41)

1 . A quality control method for a diagnostic analyzer, comprising:

performing a quality control test;

determining, with a controller, that a quality control test result is outside of a threshold;

monitoring one or more mechanical devices of the diagnostic analyzer with the controller;

receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices in response to the monitoring; and

initiating a calibration procedure in response to both the quality control test result outside of the threshold and the receiving the error code, wherein the quality control test result alone is insufficient to initiate the calibration procedure.

2 . The method of claim 1 , wherein determining, with a controller, that a result of the quality control test is outside a threshold comprises determining, with a controller, that a variance in quality control tests is outside a threshold.

3 . The method of claim 1 , wherein the diagnostic analyzer includes one or more encoders, wherein the one or more encoders are configured to monitor position of the one or more mechanical devices, and wherein the error code indicates an error with the position of the one or more mechanical devices.

4 . The method of claim 1 , wherein the diagnostic analyzer includes one or more hall-effect sensors, wherein the one or more hall-effect sensors are configured to monitor position of the one or more mechanical devices, and wherein the error code indicates an error with the position of the one or more mechanical devices.

5 . The method of claim 1 , wherein the one or more mechanical devices includes one or more motors and wherein the error code indicates an error with the one or more motors.

6 . The method of claim 5 , wherein the error with the one or more motors indicates a high current condition associated with the one or more motors.

7 . The method of claim 5 , wherein the error with the one or more motors indicates an undervoltage condition with the one or more motors.

8 . The method of claim 1 , wherein the one or more mechanical devices includes one or more movable devices and wherein the error code indicates a crash of the one or more movable devices.

9 . The method of claim 8 , wherein the one or more movable devices is a pipette.

10 . The method of claim 1 , wherein the one or more mechanical devices includes an aspiration device and wherein the error code indicates a pressure associated with the aspiration device being outside a threshold.

11 . The method of claim 1 , wherein initiating a calibration procedure comprises prompting a user to initiate a calibration procedure.

12 . The method of claim 1 , wherein initiating a calibration procedure comprises providing instructions to a user to perform a calibration procedure.

13 . The method of claim 1 , wherein initiating a calibration procedure comprises causing the diagnostic analyzer to perform an automated calibration procedure.

14 . The method of claim 1 , wherein the diagnostic analyzer includes an encoder and wherein the calibration procedure comprises aligning the encoder.

15 . The method of claim 1 , wherein the diagnostic analyzer comprises a motor and wherein the calibration procedure comprises at least one of measuring current to the motor or measuring voltage at the motor.

16 . The method of claim 1 , wherein the diagnostic analyzer includes one or more hall-effect sensors and wherein the calibration procedure comprises aligning the one or more hall-effect sensors.

17 . The method of claim 1 , wherein the diagnostic analyzer includes one or more movable devices and wherein the calibration procedure comprises aligning the one or more moving devices.

18 . The method of claim 17 , wherein the one or more movable devices is a pipette and wherein the calibration procedure comprises aligning the pipette.

19 . The method of claim 1 , wherein the diagnostic analyzer includes an aspiration device and wherein the calibration procedure comprises measuring a pressure associated with the aspiration device.

20 . The method of claim 1 , further comprising:

performing a plurality of specimen tests to obtain a plurality of specimen test results;

determining that a moving average of the plurality of specimen test results is outside of a threshold; and

initiating a second calibration procedure in response to the plurality of specimen test results being outside of the threshold and the receiving the error code.

21 . A diagnostic analyzer, comprising:

a controller configured to:

perform a quality control test;

determine that a quality control test result is outside of a threshold;

monitor one or more mechanical devices of the diagnostic analyzer;

receive an error code indicating an error in a mechanical device of the one or more mechanical devices in response to the one or more mechanical devices being monitored; and

initiate a calibration procedure in response to both the quality control test result outside of the threshold and receiving the error code, wherein the quality control test result alone is insufficient to initiate the calibration procedure.

22 . A method of operating a diagnostic analyzer, comprising:

performing quality control tests with the diagnostic analyzer, wherein a quality control test analyzes a quality control sample and has an expected result;

determining, with a controller, that a variance in the quality control tests is outside of a threshold;

monitoring one or more mechanical devices of the diagnostic analyzer with the controller;

receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices in response to monitoring of the one or more mechanical devices; and

initiating a calibration procedure by the controller in response to the variance in the quality control tests being outside of the threshold and receiving the error code, wherein the variance in the quality control tests alone is insufficient to initiate the calibration procedure.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 11, 2024
From: AHMED, MUHAMMAD
To: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Reel/Frame 067696/0312 →
Continuity (2)
Provisional Application 62948754 · Dec 16, 2019
Related Publication 20230009309A1 · Jan 12, 2023
References Cited (42)
US 6370942B1 · Dunfee et al. · 2002 [cited by applicant]
US 6735597B1 · Paradies · 2004 [cited by applicant]
US 6937955B2 · Barnes · 2005 [cited by applicant]
US 7203619B2 · Parvin et al. · 2007 [cited by applicant]
US 7359536B2 · Hays et al. · 2008 [cited by applicant]
US 7727181B2 · Rush · 2010 [cited by applicant]
US 7865314B1 · Ohm · 2011 [cited by applicant]
US 8059001B2 · Parvin et al. · 2011 [cited by applicant]
US 8099257B2 · Parvin et al. · 2012 [cited by applicant]
US 9151769B2 · Hammond et al. · 2015 [cited by applicant]
US 9483441B2 · Li et al. · 2016 [cited by applicant]
US 10395357B2 · Vivet et al. · 2019 [cited by applicant]
US 20030179445A1 · Maenle · 2003 [cited by examiner]
US 20070100569A1 · DeSimas · 2007 [cited by examiner]
US 20070198213A1 · Parvin et al. · 2007 [cited by applicant]
US 20090215183A1 · Takehara · 2009 [cited by examiner]
US 20110308313A1 · Azimi et al. · 2011 [cited by applicant]
US 20130139616A1 · Yamamoto et al. · 2013 [cited by applicant]
US 20130151189A1 · Li et al. · 2013 [cited by applicant]
US 20160356800A1 · Glavina · 2016 [cited by examiner]
US 20160370396A1 · Wasson · 2016 [cited by examiner]
US 20170370956A1 · Hurwitz et al. · 2017 [cited by applicant]
US 20180089870A1 · Billi-Duran · 2018 [cited by examiner]
US 20180289870A1 · Beasley et al. · 2018 [cited by applicant]
US 20190033209A1 · Kluckner et al. · 2019 [cited by applicant]
US 20190302136A1 · Ashida et al. · 2019 [cited by applicant]
CN 1495427A · 2004 [cited by applicant]
CN 101153858A · 2008 [cited by applicant]
CN 102439459A · 2012 [cited by applicant]
CN 104395729A · 2015 [cited by applicant]
CN 104755930A · 2015 [cited by applicant]
CN 110174587A · 2019 [cited by examiner]
JP H02284039A · 1990 [cited by applicant]
JP 2000266756A · 2000 [cited by applicant]
JP 2001330617A · 2001 [cited by applicant]
JP 2003533701A · 2003 [cited by applicant]
JP 201232309A · 2012 [cited by applicant]
JP 201949568A · 2019 [cited by applicant]
JP 2019174424A · 2019 [cited by applicant]
WO WO2015157340A1 · 2015 [cited by examiner]
PCT International Search Report and Written Opinion dated Mar. 19, 2021 (9 Pages). [cited by applicant]
Extended EP Search Report dated May 11, 2023 of corresponding European Application No. 20901659.1, 4 Pages. [cited by applicant]