BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER

    MDR report key: 1954263 · Received December 9, 2010

    Report

    Report Number
    2027969-2010-02135
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR TESTING; PRODUCT SUPPORT WAS UNABLE TO VERIFY THE CUSTOMER'S RESULT. PRODUCT SUPPORT COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTOR THAT MAY HAVE AFFECTED ANALYTE RECOVERY. TNI CORRELATION TO THE DIMENSION ANALYZER HAS NOT BEEN VERIFIED BY ALERE; PRODUCT SUPPORT COULD NOT RULE OUT SAMPLE INTERFERENCE ON THAT PLATFORM. UPON REVIEW OF THE MANUFACTURE DATA AT POUCH RELEASE AND CALIBRATION, DEVICE LOT W48318 WAS WITHIN THE MDD SPECIFICATIONS. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME, AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED A FALSE NEGATIVE TROPONIN (TNI) RESULT USING THE TRIAGE CARDIAC PROFILER. PATIENT WAS ADMITTED TO THE ER WITH CHEST PAIN. PATIENT WAS ADMITTED TO CATH LAB AND NO MI WAS CONFIRMED. DIAGNOSIS: AFIB AND AV BLOCK. LAB CUT OFF: 0.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97100CP W48318

    Patients

    Seq Age Sex Outcome Treatment
    1