BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 2624329 · Received June 15, 2012

    Report

    Report Number
    2027969-2012-00923
    Event Type
    Injury
    Date Received
    June 15, 2012
    Date of Event
    May 21, 2012
    Report Date
    June 15, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT HIGH TNI WAS OBSERVED WITH RETURNED PT SAMPLE. HAMA TESTING DID NOT SHOW ANY HAMA INTERFERENCE. RETURNED SAMPLE WAS NEGATIVE FOR TNI ON ACCESS. DEVICE LOT K50515 WAS PREVIOUSLY TESTED IN-HOUSE IN A PREVIOUS CASE. ALL RESULTS OF WHOLE BLOOD TESTING RESULTED IN TNI<0.10NG/ML, WITH THE EXCEPTION OF ONE REPLICATE. ONE RESULT >0.10NG/ML MEETS QC RELEASE SPECIFICATION. AS OF 06/05/2012, THERE ARE TOTAL OF (B)(4)COMPLAINTS AGAINST DEVICE LOT K50515. CAPA (B)(4) WAS OPENED TO ADDRESS ELEVATED TNI AT LOW END CONCENTRATIONS.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE POSITIVE TROPONIN (TNI) RESULTS. RESULTS AS FOLLOWS: PT PRESENTED WITH NAUSEA AND VOMITING; HYPERTENSIVE. PT WAS ADMITTED TO PERFORM MORE TESTING. WHOLE BLOOD EDTA SAMPLE. REFERENCE RANGE: 0.05-0.24 CUTOFF USED IN THE LAB SIEMENS DIMENSION RXL TNI CUTOFF: 0.6. PT HISTORY WAS NOT PROVIDED. CUSTOMER TO COLLECT ANOTHER EDTA SAMPLE TO SEND IN FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97000HS K50515B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization