BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPONIN T

    MDR report key: 2143317 · Received June 29, 2011

    Report

    Report Number
    1823260-2011-03506
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961500
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TROPONIN T RESULT FROM THE COBAS E411 DISK ANALYZER SERIAL NUMBER (B)(4) WHEN COMPARED TO THE TROPONIN T STAT RESULT. THE USER'S PROCEDURE IS TO RUN BOTH ASSAYS. IF THE RESULTS DIFFER BY > 10%, THE RESULTS ARE NOT REPORTED AND THE SAMPLE IS SENT TO THE REFERENCE LAB FOR THIRD ANALYSIS. THE TROPONIN T RESULT WAS 1.81 NG/ML AND THE TROPONIN T STAT RESULT WAS 2.19 NG/ML. THE SAMPLE WAS SENT TO A REFERENCE LAB FOR TESTING ON A COBAS E411 AND THE TROPONIN T STAT RESULT WAS 2.2 NG/ML WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TROPONIN T STAT REAGENT LOT NUMBER WAS 15989401. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE AND COULD NOT DUPLICATE THE PROBLEM. TO VERIFY THE ANALYZER OPERATION, HE VISUALLY INSPECTED THE MECHANICAL MOVEMENTS AND ALIGNMENTS AND RAN PERFORMANCE TESTING WITH RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROPONIN T IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 15930001

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR HEPARIN| OXYGEN