ARCHITECT 2K41-37Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00380740052836), received between Sep 23, 2016 and Aug 14, 2026 — classified as 2 injuries, 93 malfunctions.

The most frequently reported specific device problem is “High Test Results” (78 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254092 ↗
• MalfunctionApr 8, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR TWO PATIENTS ON THE ARCHITECT I2000SR PROCESSING MODULE, SERIAL NUMBER (B)(6). THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) FEMALE AGE 48 PROCESSED ON (B)(6) 2026 INITIAL RESULT = 0.23 REPEAT RESULT ON ANOTHER ARCHITECT SERIAL NUMBER (B)(6) = <0.01. SID (B)(6) MALE AGE 79 PROCESSED ON (B)(6) 2026 INITIAL RESULT = 0.05 REDRAW(SHORT SAMPLE) = 0.123 REPEATED = 0.04 TWO MORE REDRAWS = 0.07 AND 0.08. CUSTOMER¿S REFERENCE RANGE = <0.04 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820651 ↗
• MalfunctionNov 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I AND PROVIDED THE FOLLOWING DATA: SAMPLE 1: INITIAL RESULT: 1.5 NG/ML; RERUN: 0.0 NG/ML SAMPLE 2: INITIAL RUN: 1.7 NG/ML; RERUN: 0.0 NG/ML CUSTOMER CUTOFF VALUE IS 0.00-0.028 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582631 ↗
• MalfunctionOct 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2025 INITIAL RESULT AT 6:53 PM = 0.32 NG/ML REPEAT RESULTS AT 7:12 PM = <0.01 AND 7:33 PM = <0.01 NG/ML. CUSTOMER¿S REFERENCE RANGE = 0.000- 0.300 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391484 ↗
• MalfunctionJun 23, 2025High Test Results; High Test Results

  ON 07JUN2025, THE CUSTOMER REPORTED HAVING QUALITY CONTROL (QC) ISSUES WHEN USING THE ARCHITECT STAT TROPONIN-I ASSAY. THE CUSTOMER NOTED AN INSTRUMENT ERROR MESSAGE OF A STAT PIPETTOR ASPIRATION ERROR. THE CUSTOMER CALIBRATED THE STAT PIPETTOR AND QC RECOVERED WITHIN RANGE. THE ISSUE WAS OBSERVED AGAIN ON (B)(6) 2025, SO THE CUSTOMER RECALIBRATED THE ASSAY AND QC WAS WITHIN RANGE. ON (B)(6) 2025, THE CUSTOMER NOTED LEVEL 1 QC RESULT WAS OUT OF RANGE HIGH WITH A VALUE OF 0.03 (RANGE: 0.00-0.02 NG/ML). ON (B)(6) 2025, THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 0.04 NG/ML): SID (B)(6). AT 00:17, TROPONIN INITIAL RESULT = 0.40 NG/ML AT 01:23, REPEAT TROPONIN RESULT = 0.00 NG/ML REPEAT RESULT ON ANOTHER ARCHITECT ANALYZER = 0.0 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312191 ↗
• MalfunctionApr 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR AN 85-YEAR-OLD MALE PATIENT ADMITTED FOR A FALL. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL REFERENCE RANGE: </= 0.19 NG/ML): ON (B)(6) 2025, SID (B)(6). INITIAL RESULT RUN IN DUPLICATE PER LABORATORY PROCEDURE AT 12:53PM = 0.3 AND 0.28 NG/ML. RESULTS FROM 3 SUBSEQUENT DRAWS: AT 14:11 PM, SID (B)(6) = <0.03 NG/ML. AT 17:02 PM, SID (B)(6) = <0.03 NG/ML. AT 21:00 PM, SID (B)(6) = <0.03 NG/ML. THE CHIEF CARDIOLOGIST QUESTIONED THE INITIAL RESULT AFTER REVIEWING THE RESULTS FROM THE SUBSEQUENT SAMPLES. THE CUSTOMER CONFIRMS THE PATIENT WAS NOT ADMITTED AND DID NOT RECEIVE ANY TREATMENT BECAUSE OF THE ELEVATED TROPONIN-I RESULT. AS PART OF TROUBLESHOOTING, THE CUSTOMER REPEATED THE INITIAL SAMPLE (SID (B)(6)) ON (B)(6) 2025. THE CUSTOMER RAN THE SAMPLE AGAIN ON THE ORIGINAL INSTRUMENT (SN (B)(6)) AND GENERATED A RESULT OF < 0.03 NG/ML. THE CUSTOMER THEN RAN THE SAME SAMPLE ON ANOTHER ANALYZER (SN (B)(6)) AND GENERATED A RESULT OF < 0.03 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903285 ↗
• MalfunctionMar 6, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR A 27 YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <0.034, CRITICAL RANGE: >/= 0.12): 13FEB2024 SAMPLE ID (B)(6) RESULT = 0.013 NG/ML SAME PATIENT, NEW SAMPLE; SAMPLE ID (B)(6) RESULT = 0.120 NG/ML, REPEAT RESULT ON DIFFERENT ANALYZER WITH SERIAL NUMBER (B)(6)= <0.010 NG/ML SAME PATIENT, NEW SAMPLE; SAMPLE ID (B)(6) RESULT = <0.010 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851781 ↗
• MalfunctionJan 25, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR THREE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S CUT OFF FOR MALES IS 0.000-0.033 NG/ML; FOR FEMALES IS 0.000-0.013 NG/ML): SAMPLE ID (B)(6) , MALE, INITIAL RESULT, ON (B)(6) 2023, WAS 0.014, REPEATS WERE 0.579 AND 0.010 NG/ML SAMPLE ID (B)(6) , FEMALE, INITIAL RESULT, ON (B)(6) 2023, WAS 0.239, REPEATS WERE 0.000 AND 0.000 NG/ML SAMPLE ID (B)(6) , MALE, INITIAL RESULT, ON (B)(6) 2023, WAS 0.147, REPEAT WAS 0.015 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582792 ↗
• MalfunctionNov 28, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I SINCE MARCH 2023 AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE >0.028 IS CONSIDERED CRITICAL (UNIT OF MEASURE NG/ML). ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.031, REPEAT RESULTS WERE <0.019 AND <0.010. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.032, REPEAT RESULTS WERE 0.021, <0.010, <0.010. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.043, REPEAT RESULTS WERE 0.024, 0.025. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.034, REPEAT RESULTS WERE 0.025, 0.015. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.081, REPEAT RESULTS WERE 0.02, <0.010, <0.010. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.031, REPEAT RESULTS WERE <0.010, <0.010. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.033, REPEAT RESULTS WERE 0.012, 0.016. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.033, REPEAT RESULTS WERE 0.027, 0.018, 0.02. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.06, REPEAT RESULTS WERE 0.016, <0.010. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.03, REPEAT RESULTS WERE 0.02, 0.017, 0.016, 0.014. ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222425 ↗
• MalfunctionOct 17, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. (CUSTOMER¿S NORMAL REFERENCE RANGE - <= 0.04 NG/ML, CRITICAL VALUE - >= 0.10 NG/ML).SID (B)(6) ORIGINAL RESULT WAS 0.11 NG/ML (CRITICAL) (ISR63388). REPEATED ON 2ND ANALYZER TWICE (ISR63385): 0.05 NG/ML, 0.06 NG/ML. REPEATED ON ORIGINAL ANALYZER FIVE MORE TIMES (ISR63388): 0.04 NG/ML, 0.04 NG/ML, 0.04 NG/ML, 0.05 NG/ML, 0.05 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949896 ↗
• MalfunctionSep 27, 2023High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULT OF 0.12 NG/ML WAS GENERATED FOR A PATIENT SAMPLE, SID (B)(6), THAT RETESTED NEGATIVE AT 0.02 AND 0.01 NG/ML. REFERENCE RANGE: </=0.04 NG/ML, CRITICAL RANGE: >/=0.1 NG/ML. THE CUSTOMER STATED THAT ALL CRITICAL RESULTS ARE REPEATED, SO THE FALSE POSITIVE RESULT WAS NOT REPORTED OUT OF THE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827542 ↗
• MalfunctionSep 12, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <0.016 NG/ML IS NORMAL): INITIAL RESULT = 0.4167 NG/ML, REPEAT RESULT = <0.016 NG/ML, REPEAT RESULT ON ANOTHER ANALYZER = <0.016 NG/ML. NEW SAMPLE OBTAINED, RAN ON INITIAL ANALYZER WHICH GAVE RESULT = >0.016 NG/ML, RAN ON ANOTHER ANALYZER AND RESULT = >0.016 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730339 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE MULTIPLE PATIENTS. THE PHYSICIAN QUESTIONED THE RESULT WHICH INITIATED THE CUSTOMER TO RETEST MULTIPLE SAMPLES FROM THAT DAY. THE PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE ARCHITECT PROCESSING MODULE AND THE RESULTS WERE NORMAL. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: < 0.029 NG/ML ON (B)(6) 2023, SID (B)(6) ,INITIAL RESULT = 0.059 NG/ML; REPEAT RESULT = 0.012 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.043 NG/ML; REPEAT RESULT = 0.021 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.035 NG/ML; REPEAT RESULT = 0.006 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.040 NG/ML; REPEAT RESULT = 0.009 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.053 NG/ML; REPEAT RESULT = 0.018 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.040 NG/ML; REPEAT RESULT = 0.010 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.095 NG/ML; REPEAT RESULT = 0.014 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.043 NG/ML; REPEAT RESULT = 0.019 NG/ML. ON (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.044 NG/ML; REPEAT RESULT = 0.017 NG/ML

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17724395 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE PHYSICIAN QUESTIONED THE RESULT WHICH INITIATED THE CUSTOMER TO RETEST MULTIPLE SAMPLES FROM THAT DAY. THIS PATIENT SAMPLE WAS REPEATED ON AN ALTERNATE ARCHITECT PROCESSING MODULE AND THE RESULT WAS NORMAL. THE CUSTOMER STATED THE PATIENT WAS GIVEN HEPARIN DUE TO THE FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT IN CONJUNCTION WITH AN ABNORMAL ECG. HOWEVER, IT WAS NOTED THAT HEPARIN TREATMENT WAS GIVEN AFTER THE ARCHITECT STAT TROPONIN-I RESULT WAS CORRECTED. THERE IS NO INFORMATION AS TO THE IMPACT ON THE PATIENT¿S HEALTH. THE CUSTOMER STATED THE PATIENT WAS DISCHARGED HOME FOR CARDIOLOGY FOLLOW-UP. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: < 0.029 NG/ML PATIENT 2 (B)(6)2023 SID (B)(6)INITIAL RESULT = 0.143 NG/ML; REPEAT RESULT = 0.000 NG/ML NO FURTHER ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17722370 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE PHYSICIAN QUESTIONED THE RESULT WHICH INITIATED THE CUSTOMER TO RETEST MULTIPLE SAMPLES FROM THAT DAY. THIS PATIENT SAMPLE WAS REPEATED ON AN ALTERNATE ARCHITECT PROCESSING MODULE AND THE RESULT WAS NORMAL. THE CUSTOMER STATED THE PATIENT WAS GIVEN HEPARIN UNNECESSARILY DUE TO THE FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT. HEPARIN TREATMENT STARTED ON (B)(6)2023 AT 16:30 AND WAS DISCONTINUED ON (B)(6)2023 AT 18:39 BY THE CLINICIAN WHEN NOTIFIED WITH CORRECTED RESULT. THERE IS NO INFORMATION AS TO THE IMPACT ON THE PATIENT¿S HEALTH. THE CUSTOMER STATED THE PATIENT WAS DISCHARGED HOME FOR CARDIOLOGY FOLLOW-UP. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: < 0.029 NG/ML PATIENT 1 (B)(6)2023 SID (B)(6)INITIAL RESULT = 0.045 NG/ML; REPEAT RESULT = 0.006 NG/ML NO FURTHER ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17721540 ↗
• MalfunctionJul 19, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR A PATIENT. THE RESULT WAS NOT REPORTED OUT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0.01-0.013 NG/ML): INITIAL RESULT COMING OUT OF STORAGE ON TRACK SYSTEM = 0.019 NG/ML, REPEAT RESULT AFTER BEING RESPUN = 0.008 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352312 ↗
• MalfunctionMay 22, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S CUTOFF IS 0.30 NG/ML): SAMPLE ID (B)(6) INITIAL RESULT WAS 1.19 NG/ML, WHICH WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 0.0 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16980487 ↗
• MalfunctionApr 19, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED. SID: (B)(6) (67 YEAR OLD FEMALE), (B)(6) 2023, INITIAL RESULT: 0.33 NG/ML (CRITICAL), REPEAT RESULTS: 0.04 AND 0.03 NG/ML (NORMAL). NORMAL RANGES: NORMAL = </= 0.03 NG/ML, INTERMEDIATE = 0.04 - 0.29 NG/ML, CRITICAL = >/=0.3 NG/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773051 ↗
• MalfunctionApr 19, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <0.034 NG/ML): (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT = 0.619 NG/ML, SAMPLE REPEATED 10 TIMES ON SAME INSTRUMENT AND RESULTS = 0.011 NG/ML, 0.012 NG/ML, 0.017 NG/ML, 0.011 NG/ML, 0.012 NG/ML, 0.01 NG/ML, 0.012 NG/ML, < 0.010 NG/ML, 0.01 NG/ML, 0.012 NG/ML, < 0.01 NG/ML. SAMPLE REPEATED 8 TIMES ON ANOTHER INSTRUMENT ISR63497 AND RESULTS = 0.015 NG/ML, 0.017 NG/ML, 0.013 NG/ML, 0.013 NG/ML, 0.016 NG/ML, 0.014 NG/ML, 0.011 NG/ML, 0.012 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769287 ↗
• MalfunctionMar 30, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON TWO PATIENTS. RESULTS PROVIDED: SID. DATE. INITIAL / REPEAT. LOT# . (B)(6). (B)(6). 0.316 / <0.010 / <0.010 NG/ML. 95418UN22. (B)(6). (B)(6). 0.032 / <0.010 / <0.010 NG/ML. 95418UN22. NORMAL RANGE: 0.000 - 0.028 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644493 ↗
• MalfunctionMar 30, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON FOUR PATIENTS. RESULTS PROVIDED: SID DATE INITIAL / REPEAT LOT# (B)(6). (B)(6). 0.029 / <0.010 / <0.010 NG/ML 32677UN22 .(B)(6). (B)(6). 0.035 / <0.010 / 0.024 NG/ML 32677UN22. (B)(6). (B)(6). 0.038 / <0.010 / <0.010 NG/ML 32677UN22. (B)(6). (B)(6). 0.031 / 0.02 / <0.010 NG/ML 32677UN22. NORMAL RANGE: 0.000 - 0.028 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644459 ↗
• MalfunctionFeb 24, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE 74 YEAR-OLD FEMALE PATIENT WITH CHEST PAIN. NO MEDICAL TREATMENT WAS GIVEN TO PATIENT BASED ON INITIAL RESULT. THE PATIENT WAS ONLY MOVED TO STEPDOWN ROOM FOR OBSERVATION BASED ON INITIAL RESULT. ANOTHER SAMPLE FROM SAME PATIENT WAS RAN AND THE RESULT WAS IN THE CUSTOMER¿S NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) SAMPLES PROCESSED ON 06FEB2023 INITIAL RAN AT 2:30 AM RESULTS = 0.95 REPEAT USING ANOTHER TUBE DRAWN AT SAME TIME AS FIRST TUBE RESULT WAS NEGATIVE CUSTOMER PULLED ORIGINAL TUBE AND CENTRIFUGED AS WAS A SHORT DRAW AND POSSIBLE FIBRIN RAN AT 5:00 AM REPEAT RESULT = 0.02 PRECISION STUDY W/ SPECIMEN AFTER REPEAT RESULTS = 0.02,0.02,0.02,0.02,0.06 CUSTOMER¿S REFERENCE RANGE IS <=0.03 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436700 ↗
• MalfunctionJan 5, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT. THE SECOND SAMPLE DRAWN FROM THIS PATIENT GENERATED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT WHICH WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT AND THE QUESTIONED RESULT (SAMPLE 2) REPEATED LOWER. IT IS SUSPECTED THE FALSELY ELEVATED RESULT WAS DUE TO PREANALYTICAL ERROR. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: </=0.03 IS NEGATIVE; 0.04-0.29 IS INDETERMINATE; >/= 0.3 IS POSITIVE UNIT OF MEASURE = NG/ML ON (B)(6) 2022: (B)(6) INITIAL RESULT = 0.02 NG/ML, REPEAT RESULT (ISR63038) = 0.02 NG/ML. (B)(6) INITIAL RESULT = 1.42 NG/ML, REPEAT RESULT (ISR63038) = 0.01 NG/ML. (B)(6) INITIAL RESULT = 0.02 NG/ML, REPEAT RESULT (ISR63038) = 0.02 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108204 ↗
• MalfunctionNov 17, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS IN THE CUSTOMERS NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 0.11 NG/ML, REPEAT RESULT = <0.03 NG/ML. CUSTOMER¿S REFERENCE RANGE IS <0.03 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819771 ↗
• MalfunctionNov 2, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS <0.03 NG/ML): INITIAL RESULT WAS 0.21 NG/ML, WHICH WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS THEN REPEATED, AND THE RESULT WAS <0.01 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718839 ↗