BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 11866550 · Received May 21, 2021

    Report

    Report Number
    3005094123-2021-00099
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 8, 2021
    Report Date
    July 1, 2021
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT STAT HIGH SENSITIVE TROPONIN-I, LIST 3P25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I, LIST 2R98. AN EVALUATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION D4, CATALOGUE NUMBER WAS CORRECTED TO 03P25-37; AND SECTION H10 THE SIMILAR US PRODUCT STATEMENT WAS ADDED. THESE CORRECTIONS/ADDITIONS DO NOT CHANGE THE INTENT OF THE DOCUMENT AND ONLY PROVIDE THE CORRECTED/OMITTED INFORMATION.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, ATTACHED DATA, TRENDING DATA, LABELLING, DEVICE HISTORY RECORDS AND FIELD DATA. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRENDING REPORTS IDENTIFIED NO TRENDS RELATED TO THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW FOR LOT 25066UD00 DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. HISTORICAL PERFORMANCE OF REAGENT LOT 25066UD00 WAS EVALUATED USING DATA FROM WORLDWIDE CUSTOMERS. THE PATIENT MEDIAN RESULT FOR THE LOT IS COMPARABLE WITH OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I LOT NUMBER 25066UD00 WAS IDENTIFIED.SECTION A2 AGE UNITS (YEARS) AND SECTION A3 GENDER (FEMALE) WERE ENTERED. THE FIELDS WERE INADVERTENTLY LEFT BLANK IN THE PREVIOUS REPORTS. THIS CORRECTION DOES NOT CHANGE THE INTENT OF THE DOCUMENTED INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A 44 YEAR OLD FEMALE ROMANIAN PATIENT. SAMPLE ID (B)(6) GENERATED AN INITIAL POSITIVE RESULT OF 66.5 PG/ML. NEGATIVE RESULTS WERE GENERATED WHEN THE SAMPLE WAS RETESTED ON THE ORIGINAL ARCHITECT (0 AND 0 PG/ML) AND ALTERNATE ARCHITECT (0.2 AND 0 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A (B)(6) YEAR OLD FEMALE ROMANIAN PATIENT. SAMPLE ID (B)(6) GENERATED AN INITIAL POSITIVE RESULT OF 66.5 PG/ML. NEGATIVE RESULTS WERE GENERATED WHEN THE SAMPLE WAS RETESTED ON THE ORIGINAL ARCHITECT (0 AND 0 PG/ML) AND ALTERNATE ARCHITECT (0.2 AND 0 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761586 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 25066UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR ARC I2000SR INST, 03M74-02, ISR60890