BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB 25 TEST KIT

    MDR report key: 2142557 · Received June 20, 2011

    Report

    Report Number
    2027969-2011-01366
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE TROPONIN I (TNI) RESULTS ON ONE LOT OF STRIPS VS. POTENTIAL FALSE POSITIVE TNI RESULTS ON THE SECOND LOT TESTED. THE CALLER WAS PERFORMING A LOT TO LOT COMPARISON STUDY. NINE PATIENT WHOLE BLOOD SAMPLES WERE RANDOMLY RUN SIDE BY SIDE USING TWO LOTS OF SOB ON ONE METER. THE CUSTOMER'S TROPONIN I CUT OFF IS 0.05. TWO PATIENT SAMPLES GAVE NEGATIVE RESULTS ON ONE LOT AND POSITIVE ON THE OTHER. CALLER WAS FINE WITH SEVEN OF THE RESULTS BECAUSE, THEY WERE EITHER <0.05 OR >0.05 ON BOTH DEVICE LOTS EVEN THOUGH THERE IS SOME DIFFERENCES IN READINGS BETWEEN THE TWO LOTS. NO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE PROFILER SOB 25 TEST KIT CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97300 W48925

    Patients

    Seq Age Sex Outcome Treatment
    1