BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

    MDR report key: 5414010 · Received February 5, 2016

    Report

    Report Number
    2027969-2016-00078
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    December 26, 2015
    Report Date
    January 15, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE (CONTINUED): DDR, JHX AND MMI. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY FOR LOT W60030RB WAS PERFORMED AND NO DISCREPANCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. SINCE NO SAMPLE WAS RETURNED, SAMPLE SPECIFIC INTERFERENCE IS UNABLE TO BE RULED OUT AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. BASED ON THE INFORMATION AVAILABLE, THE PRODUCT PERFORMED AS EXPECTED. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A VARIANCE BETWEEN THE TRIAGE TROPONIN (TNI) RESULT AND THE LABORATORY TNI RESULT. ON (B)(6) 2015, A (B)(6) FEMALE PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE TRIAGE TNI RESULT WAS 0.27 AT 12:14 AND THE LABORATORY TNI WAS <0.03 AT 13:00. BOTH RESULTS WERE FROM THE SAME SAMPLE DRAW. THE CUSTOMER HAD NO CONCERNS ABOUT SAMPLE QUALITY AS IT WAS CHECKED FOR HEMOLYSIS, CLOTS, LIPEMIA, ETC. ELECTROCARDIOGRAM (EKG) WAS PERFORMED BUT THE RESULT WAS NOT AVAILABLE PER CUSTOMER. ADDITIONAL LABORATORY TESTING AS FOLLOWS: (B)(6). THERE WERE NO INVASIVE PROCEDURES PERFORMED AND THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH THE FOLLOWING DIAGNOSIS: CHEST WALL MUSCLE SPASM, HYPERTENSION, TOBACCO USE AND URINARY TRACT INFECTION (UTI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71597 TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97022HS W60030RB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR MEDROXYPROGESTERONE (DEPO-PROVERA) 150MG/ML 3 MOS