BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 5370750 · Received January 15, 2016

    Report

    Report Number
    2027969-2016-00030
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 8, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVICE CODE (CONTINUED): DAP, DDR, JHX AND MMI. INVESTIGATION/CONCLUSION: THE PHYSICIAN'S OFFICE WAS UNABLE TO 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 REVIEWED, TRACKED AND TRENDED. ALL COMPLAINTS ARE REVIEWED, TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: REPORT SOURCE CORRECTED TO REMOVE COMPANY REPRESENTATIVE AND INCLUDE CONSUMER.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). A PATIENT WAS TESTED IN THE PHYSICIAN'S OFFICE WITH THE TRIAGE SOB PANEL AND RECEIVED A D-DIMER RESULT OF 3000 NG/ML. THE PATIENT WAS LATER TESTED AT THE HOSPITAL AND THE LABORATORY D-DIMER RESULT WAS NEGATIVE AT 300 NG/ML. A COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED AND A TUMOR WAS FOUND. THERE WAS NO ADVERSE PATIENT SEQUELA. 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
    29401 TRIAGE PROFILER SOB PANEL CARDIAC MARKER TEST, NBC ALERE SAN DIEGO, INC. 97300EU

    Patients

    Seq Age Sex Outcome Treatment
    1