BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPONIN T STAT (SHORT TURN AROUND TIME)

    MDR report key: 2112388 · Received June 3, 2011

    Report

    Report Number
    1823260-2011-02988
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 22, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K051752
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE FOR THIS EVENT COULD NOT BE IDENTIFIED. IN THIS CASE, THE FALSELY HIGH RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY, THEREFORE THE PATIENT WAS NOT AFFECTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TROPONIN T RESULTS WHEN COMPARING THE TROPONIN T STAT ASSAY TO THE TROPONIN T ASSAY ON THE COBAS E411 DISK ANALYZER SERIAL NUMBER (B)(4). THE TROPONIN T STAT RESULT WAS 0.059 NG/ML WITH A DATA FLAG AND WAS ROUNDED TO 0.06 NG/ML BY THE LABORATORY INFORMATION SYSTEM (LIS). THE TROPONIN T RESULT WAS <0.010 NG/ML WITH A DATA FLAG AND WAS ROUNDED TO <0.01 NG/ML BY THE LIS. PER THE LABORATORY PROTOCOL, SINCE THE RESULTS DID NOT AGREE WITHIN 0.02 NG/ML, THE USER SENT THE SAMPLE TO ANOTHER HOSPITAL FOR TESTING ON ANOTHER COBAS E411. THE TROPONIN T STAT RESULT WAS <0.010 NG/ML AND THE TROPONIN T RESULT WAS <0.010 NG/ML. THE USER STATED THE RESULT OF <0.010 NG/ML "WAS WHAT THEY WERE GOING WITH". THE ORIGINAL TROPONIN T STAT RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TROPONIN T REAGENT LOT NUMBER WAS 15930001. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE AND COULD NOT REPRODUCE THE PROBLEM. HE CHECKED THE MECHANICAL ALIGNMENT OF THE PROBE AND SIPPER SYSTEMS. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING WITH RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROPONIN T STAT (SHORT TURN AROUND TIME) IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 15989401

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR