BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 9732647 · Received February 20, 2020

    Report

    Report Number
    1415939-2020-00017
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 28, 2020
    Report Date
    February 27, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    UDI-DI
    00380740048525
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 61975UN19 IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY BUT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. A REVIEW OF FIELD DATA WAS EVALUATED AND THE PATIENT MEDIAN RESULT FOR LOT 61975UN19 WAS FOUND TO BE WITHIN ESTABLISHED BASELINES AND CONFIRMS THE PERFORMANCE OF THIS LOT IS NOT COMPROMISED. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT ON A (B)(6) MALE PATIENT. RESULTS PROVIDED: (B)(6) 2028 (B)(6) = 421 / 471 NG/L(CUSTOMER CUT OFF=33NG/L); NEW SAMPLE 3 HOURS LATER (B)(6) = 453 / 498 NG/L; BOTH SAMPLES ON I-STAT = ZERO; ANOTHER FACILITY VISTA TROPONIN-I = NEGATIVE (< 16 NG/L); ARCHITECT STAT TROPONIN-I (B)(6) 2018 = 981 / 1205 NG/L; (B)(6) 2017 = 448 NG/L, ANOTHER FACILITY VISTA = 16 NG/L, PERFORMED MONOCLONAL AB TEST=<6 NG/ML(NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195757 ARCHITECT STAT TROPONIN-I TROPONIN-I MMI ABBOTT LABORATORIES 2K41-27 61975UN19 00380740048525

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR ARCHITECT I1000SR ANALYZER LIST 01L86-40.| ARCHITECT I1000SR ANALYZER.| LN 01L86-40, SERIAL (B)(6).| SERIAL (B)(6).