BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 2627136 · Received June 21, 2012

    Report

    Report Number
    2027969-2012-00963
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 23, 2012
    Report Date
    June 21, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(4) 2012 THERE ARE A TOTAL OF TWELVE (12) COMPLAINTS AGAINST CARDIAC LOT K50515. DEVICE LOT NUMBER K50515 WAS PREVIOUSLY TESTED. ALL RESULTS OF WHOLE BLOOD TESTING RESULTED IN TNI<0.10NG/ML, WITH THE EXCEPTION OF ONE REP. ONE RESULT >0.10NG/ML MET QUALITY CONTROL RELEASE SPECIFICATION. NO SAMPLE ASSOCIATED WITH THE COMPLAINT IS EXPECTED FOR RETURN. WITHOUT SAMPLE RETURNED FOR ANALYZING, SPECIFIC SAMPLE INTERFERENCE COULD NOT BE RULED OUT. CAPA (B)(4) WAS OPENED TO ADDRESS ELEVATED TNI AT LOW END CONCENTRATIONS.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT HIGH TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL TEST VS SIEMENS DIMENSION RXL. PATIENT HAD CHEST PAIN. NO FINAL DIAGNOSIS WAS PROVIDED. NO PATIENT HISTORY WAS PROVIDED. NO TREATMENT BASED ON TRIAGE RESULT. NO INVASIVE PROCEDURE BASED ON TRIAGE RESULT. ELECTROCARDIOGRAM (EKG) WAS PERFORMED; RESULTS WERE NOT PROVIDED. EMPLOY GREY ZONE: 0.05-0.4. ON (B)(6) 2012, CUSTOMER DID NOT HAVE SUFFICIENT VOLUME FOR INVESTIGATION TESTING. ALSO SAMPLE WAS COLLECTED INAPPROPRIATELY. FULL DRAW TUBE NOT COLLECTED, TUBE WAS ABOUT 2/3 FULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL TEST CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97000HS K50515B

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR