BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 2030231 · Received March 21, 2011

    Report

    Report Number
    2027969-2011-00550
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT SAMPLE RETURNED BY CUSTOMER. NONE OF THE RESULTS PROVIDED BY THE CUSTOMER WERE ABOVE THE CLINICAL CUTOFF OF 0.40NG/ML THAT REPRESENTS A POSITIVE RESULT. PRODUCT SUPPORT PREVIOUSLY CONDUCTED TESTING ON CARDIAC W48710 FOR ANOTHER COMPLAINT. PRODUCT SUPPORT CONDUCTED TESTING WITH CALIBRATOR Z (NEGATIVE CONTROL) AND CALIBRATOR H (POSITIVE CONTROL) ON CARDIAC W48710. OBSERVATIONS ARE FOR TNI RECOVERY. CAL H: ONE DATA POINT WITH CAL H WAS BELOW THE MFG 2SD RANGE (N=10). PERCENT RECOVERY WAS 77%. WITHIN MFG SPECS. CAL Z: ALL DATA POINTS WITH CAL Z WERE BELOW THE MFG 2SD RANGE. NO FALSE POSITIVES WERE OBSERVED WITH CAL Z. NO ERROR CODES OR DEVICE ISSUES WERE OBSERVED. CUSTOMERS HIGH MYO COULD BE CAUSED BY HIGH LAB TEMPERATURES AND MYO RECOVER IS KNOWN TO BE ELEVATED IN THESE CONDITIONS. NO PRODUCT DEFICIENCY WAS ESTABLISHED; NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE POSITIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL TEST. CUSTOMER RAN SAMPLES FROM TWO DIFFERENT ED PTS. THE INITIAL RUN GAVE HIGHER RESULTS THAN THE REPEAT. THE CALLER SAID THAT THE MYO RESULTS WERE ALSO ELEVATED BUT NO VALUES WERE PROVIDED. THE CLINICAL FINDINGS DO NOT EQUAL RESULTS FROM THE TESTING. THE CALLER INDICATED THAT THE TEMPERATURE IN THE TESTING AREA OF THE ED WHERE THE METERS ARE LOCATED HAS BEEN VERY HOT (CUSTOMER HAS TO OPEN THE DOOR SOMETIMES TO COOL IT DOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS W48710

    Patients

    Seq Age Sex Outcome Treatment
    1