BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 3884174 · Received May 19, 2014

    Report

    Report Number
    2027969-2014-00440
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANT LOW TNI RESULTS WERE OBSERVED DURING CAL H TESTING ON RETAIN LOT W56224. DEVICE LOT W56224 MET PACKAGE INSERT CLAIM. RETURN SAMPLES YIELDED SIMILAR RESULTS ON TWO CARDIAC HS LOTS. NUMBER OF RETURNED DEVICES WAS NOT ENOUGH TO GENERATE A STATISTICALLY RELEVANT DATA SAMPLE SIZE. THE ONLY DIAGNOSIS CUSTOMER WAS ABLE TO PROVIDED PT WAS ANGINA DIAGNOSIS. THERE ARE FOUR TYPES OF ANGINA AND THEY DIFFER BY SYMPTOMS AND TREATMENTS. IN MOST CASES ANGINA DOES NOT INCREASE TROPONIN I. CUSTOMER WAS UNABLE TO PROVIDE ADD'L PT INFO, CUSTOMER STATED THE PT WAS TREATED BASED ON THE ARCHITECT VALUE. NO PRODUCT DEFICIENCY WAS ESTABLISHED, PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE TBI RESULTS. RESULTS AS FOLLOWS: PT PRESENTED WITH ANGINA. PT WAS SENT FOR FURTHER CARE. ACTION WAS TAKEN BASED ON THE REFERENCE RESULTS. TRIAGE: TNI: <0.05. SAMPLE: WB EDTA. REFERENCE: TNI: 0.5. SAMPLE PLASMA. TESTS WERE DONE WITHIN MINUTES OF EACH OTHER. THE FOLLOWING REF RANGES WERE USED: NORMAL RANGE FOR TRIAGE: <0.05 NG/ML. NORMAL RANGE FOR ARCHITECT: 0.02-0.28 NG/ML. NO OTHER PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295443 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST MMI ALERE SAN DIEGO INC 97000HS W56224B

    Patients

    Seq Age Sex Outcome Treatment
    1 REF METHOD: ARCHITECT