BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 2586705 · Received May 22, 2012

    Report

    Report Number
    2027969-2012-00761
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT SAMPLES WERE RETURNED FOR INVESTIGATION. PRODUCT SUPPORT TESTED CALIBRATOR H AND THREE "NORMAL" (APPARENTLY HEALTHY) WHOLE BLOOD EDTA DONORS SPIKED TO TWO ELEVATED TNI CONCENTRATIONS ON THE CARDIAC LOT K50512. NO DISCREPANT OR LOW BIAS WAS OBSERVED WITH ANY SAMPLES. PRODUCT SUPPORT WAS UNABLE TO VERIFY CUSTOMER'S RESULTS AND COULD NOT RULE OUT SAMPLE SPECIFIC INTERFERENCES. AS OF 05/21/2012, THERE ARE (B)(4) COMPLAINTS AGAINST DEVICE LOT K50512 INVOLVING TNI RECOVERY. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE TROPONIN (TNI) ON THE TRIAGE CARDIAC PANEL COMPARED TO THE LAB BECKMAN DXI ACCESS DEVICE. A (B)(6) MALE PT PRESENTED WITH CHEST PAIN. WHOLE BLOOD EDTA SAMPLES WERE USED FOR THE TRIAGE METER AND LI HEPARIN SAMPLES WERE USED FOR THE LAB METER. PT'S CLINICAL OUTCOME WAS RAISED C-REACTIVE PROTEIN. PT WAS DIAGNOSED WITH MYOCARDITIS AND HE HAD SOME ABNORMAL CHANGES ON HIS ELECTROCARDIOGRAM (ECG). ECG SHOWED LBBB (LEFT BUNDLE BRANCH BLOCK) AND LEFT VENTRICULAR DYSFUNCTION. PT WAS ADMITTED TO THE CCU (CORONARY CARE UNIT). NO OTHER PT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC TRIPLE MARKER PANEL CARDIAC MARKER PANEL MMI ALERE SAN DIEGO, INC. 97000HS K50512D

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization