BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 5623020 · Received May 1, 2016

    Report

    Report Number
    2027969-2016-00267
    Event Type
    Malfunction
    Date Received
    May 1, 2016
    Date of Event
    March 8, 2012
    Report Date
    March 8, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: DAP, DDR, JHX, MMI. INVESTIGATION/CONCLUSION: FURTHER INVESTIGATION CANNOT BE PURSUED BECAUSE THERE IS NO LOT NUMBER/SERIAL NUMBER AND PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF CUSTOMER INTERACTION RECORDS AS PART OF AN INTERNAL ALERE (B)(4) CAPA (CAPA-(B)(4)) RELATED TO COMPLAINTS RECEIVED AT PARTICULAR ALERE INTAKE SITES THAT WERE NOT APPROPRIATELY FORWARDED TO ALERE (B)(4) FOR INVESTIGATION AND REPORTABILITY DETERMINATION. THE AVAILABLE INFORMATION IS LIMITED AND NO ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED. THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER REPORTED THAT A PATIENT PRESENTED TO THE OFFICE AND BLOOD WORK WAS PERFORMED AND SENT TO THE HOSPITAL. IN AN EFFORT TO KEEP THE PATIENT FROM WAITING LONG FOR THE LABORATORY RESULTS, A TRIAGE TESTING WAS PERFORMED. THE TROPONIN I RESULT WAS 0.35 (OK PER PHYSICIAN) IN ADDITION TO NORMAL MYOGLOBIN AND CK-MB. THE LABORATORY RESULTS SHOWED THAT THE PATIENT HAD A "HEART ATTACK." THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278070 TRIAGE PROFILER SOB PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97300EU

    Patients

    Seq Age Sex Outcome Treatment
    1