BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, TRIAGE PROFILER SOB PANEL

    MDR report key: 2665357 · Received July 19, 2012

    Report

    Report Number
    2027969-2012-01099
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    June 13, 2012
    Report Date
    July 19, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K042723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANT OR HIGH BIAS IN TNI RECOVERY WAS OBSERVED WITH ANY OF THE 10 WHOLE BLOOD EDTA DONORS (N=6/DONOR) ON S.O.B. LOT K51305. NO BNP RESULTS ABOVE 00 WERE OBSERVED WITH ANY OF 10 WHOLE BLOOD EDTA DONORS (N=6/DONOR) ON S.O.B. LOT K51305. NO SAMPLE WAS RETURNED FOR TESTING. SAMPLE INTERFERENCE CANNOT BE RULED OUT. NO PRODUCT DEFICIENCY WAS ESTABLISHED. ALL RESULTS OF THE TESTING MET THE RELEASE REQUIREMENT FOR THE DEVICE. AS OF (B)(4) 2012 THIS IS THE ONLY COMPLAINT OF LOT K51305. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE POSITIVE TROPONIN (TNI) RESULTS. RESULTS AS FOLLOWS: PT WITH DYSPNEA FOR SEVERAL WEEKS; NYHA II, UNSTABLE LEFT SIDED CHEST PAIN AND BNP MILDLY INCREASED. PT WAS SEEN IN PHYSICIAN'S OFFICE AND THEN SENT TO THE HOSPITAL FOR DIAGNOSTIC CATHETERIZATION WHERE NORMAL BLOOD VALUES WERE FOUND. DIAGNOSIS: DISCRETE CORONARY SCLEROSIS, GOOD SYSTOLIC, PATHOLOGIC DIASTOLIC LEFT VENTRICULAR FUNCTION (LVEDP 22MM HG). THE FOLLOWING CUT OFF'S WERE USED: CKMB: >4.3, MYO: >107, TNI: >0.40, BNP: >100, DDIM: >400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, TRIAGE PROFILER SOB PANEL CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 973000EU 51305RB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization