BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 2632946 · Received June 27, 2012

    Report

    Report Number
    2027969-2012-00992
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 27, 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 K50515 WAS PREVIOUSLY TESTED AND ALL RESULTS OF WHOLE BLOOD TESTING RESULTED IN TNI <0.10NG/ML, WITH THE EXCEPTION OF ONE REPLICATE. ONE RESULT >0.10NG/ML MEETS QUALITY CONTROL RELEASE SPECIFICATION. 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 FALSE POSITIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL TEST VS SIEMENS DIMENS RESULTS. PATIENT A WENT THROUGH THE EMERGENCY DEPARTMENT (ED) WITH INITIAL CONDITION OF WEAKNESS; PATIENT WAS NOT ADMITTED. NO FINAL DIAGNOSIS WAS PROVIDED; PATIENT WAS SENT TO EITHER A SKILLED NURSING FACILITY OR A HOME HEALTH. NO INVASIVE PROCEDURE PERFORMED. NO REFERRAL TO CARDIOLOGIST. CALLER STATED THAT THERE IS NO SAMPLE AVAILABLE TO SUBMIT FOR INVESTIGATION. SAMPLE TYPE: EDTA-WHOLE BLOOD (WB).

    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 72 YR