BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 4058451 · Received August 25, 2014

    Report

    Report Number
    2027969-2014-00776
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED VALUES WERE WITHIN THE 95% TWO-SIDED LIMITS OF THE TRIAGE DEVICE RESULTS WERE ALSO WITHIN 1 STANDARD DEVIATION. NO FURTHER INVESTIGATION WILL BE PURSUED. AS THERE IS NO INDICATION OF A PRODUCT DEFICIENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT LOW TNL. CUSTOMER REPORTED POOR TNI CORRELATION: TRIAGE METERS (IN ED) =<0.05 (3X), ACCESS2=0.060, 0.068. 0.065. REFERENCE RANGE: TRIAGE METER: NORMA. 0.0-0.09. ACCESS 2=0.0-0.039. PURPLE EDTA-WB TUBE FOR TRIAGE METER (ONE TUBE MAY HAVE NOT BEEN A FULL-DRAW), GREEN TOP TUBE FOR ACCESS2; TESTED IMMEDIATELY UPON COLLECTION; VISUAL INSPECTION OF TUBES: OK, NOTHING UNUSUAL; KITTED PIPETTES USED; MIXED WELL PRIOR TO TESTING; QCD, QC AND CAL VERS PASSED AS EXPECTED; 3 TRIAGE METERS IN ED WERE UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513558 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS W57717

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS2 ANALYZER