BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 20089281 · Received August 28, 2024

    Report

    Report Number
    1823260-2024-02489
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 3, 2024
    Report Date
    November 6, 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

    A GENERAL REAGENT ISSUE WAS EXCLUDED. THE INVESTIGATION FOUND THAT THE GEAR PUMP HEAD AND SYRINGE SEAL NEED TO BE REPLACED. THE CENTRIFUGATION TIME AND FORCE WAS 11 MINUTES AT 2200 X G INSTEAD OF THE RECOMMENDED 10 MINUTES AT 1300 - 2000 X G OR 5 MINUTES AT 3000 X G BY THE TUBE MANUFACTURER BD. FURTHER INVESTIGATION COULD NOT BE PERFORMED DUE TO THE LACK OF INFORMATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 409 PG/ML. THE REPEATED RESULT WAS 26.2 PG/ML. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 27 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465116 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 77052801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown