BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC HIGHSENSITIVITY

    MDR report key: 2489465 · Received March 8, 2012

    Report

    Report Number
    2027969-2012-00305
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    January 27, 2012
    Report Date
    March 5, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT OBSERVED 1 OUT OF 8 WHOLE BLOOD TESTS WITH AN ELEVATED TNI RESULT. THE RESULT MEETS QC RELEASE SPECIFICATIONS. CUSTOMER REPORTED OUT OF RANGE RESULTS FOR CK-MB, AND MYO ON TRIAGE WHICH CORRELATES WITH THE POSITIVE TNI VALUE. NO SAMPLE WAS RETURNED FOR TESTING. CUSTOMER DID NOT HAVE KNOWLEDGE OF MEDICATION LIST, MEDICAL HISTORY, OR IF THEY WERE ADMITTED. PRODUCT SUPPORT COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTOR THAT MAY HAVE AFFECTED ANALYTE RECOVERY. AS OF 3/2/2012, 1 SIMILAR COMPLAINT WAS REPORTED AGAINST DEVICE LOT K50510. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE POSITIVE TNI RESULTS FOR ONE PT. PT HAD PAINS 1 WEEK AGO. RESULTS ON TRIAGE IS FOR PLASMA AT 6PM: TNI = 0.2, MYO = >500, CKMB = OUT OF RANGE. PT CAME TO THE HOSPITAL AND HE HAD THE FOLLOWING DAY AT 0H36AM, TROPONIN NEGATIVE (ARCHITECT SYSTEM). AT 5PM, HE HAD CORONOGRAPHIE AND RESULT IS NEGATIVE. SAMPLE: PLASMA EDTA. TRIAGE CUT OFF IS 0.05 FOR TROPONIN. ARCHITECT CUT OFF SHOULD BE 0.03. DIAGNOSIS: WALDENSTROM DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC HIGHSENSITIVITY CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS K50510B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other