BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 20089416 · Received August 28, 2024

    Report

    Report Number
    1823260-2024-02488
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 2, 2024
    Report Date
    October 2, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE ALARM TRACE SHOWED ABNORMAL ASPIRATION ALARMS ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THE WHEELS ON THE ACTIVE GRIPPER WERE PARTLY COVERED WITH DUST. IMAGES OF THE SAMPLE SHOWED A WHITE LAYER ABOVE THE SEPARATION GEL. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH A SAMPLE QUALITY ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FOR 1 PATIENT ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 42.70 NG/L THE REPEATED RESULTS WERE 32.10 NG/L AND 28.10 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 24.30 NG/L. THE SAMPLE WAS REPEATED ON A DIFFERENT MODULE AND THE RESULT WAS 21.60 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128513 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 74279901

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male