BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 5399523 · Received January 29, 2016

    Report

    Report Number
    2027969-2016-00060
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 22, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE (CONTINUED): DDR, JHX AND MMI INVESTIGATION/CONCLUSION: THE CUSTOMER DID NOT PROVIDE A LOT NUMBER OR RETURN ANY PRODUCTS FOR INVESTIGATION. SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. ALL COMPLAINTS ARE TRACKED AND MONITORED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, AN EMAIL WAS RECEIVED FROM THE CUSTOMER QUESTIONING TRIAGE CK-MB AND MYOGLOBIN RESULTS ON (B)(6) 2016. THE RESULTS ARE AS FOLLOWS: (B)(6). THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULTS. THOUGH REQUESTED, THE ONLY INFORMATION THE CUSTOMER WAS ABLE TO PROVIDE REGARDING THE PATIENT WAS THAT THE ELECTROCARDIOGRAM (EKG) AND CHEST X-RAY WERE NEGATIVE AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57949 TRIAGE CARDIAC TRIPLE MARKER PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE MONITOR SN UNKNOWN