BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER 25 TEST KIT

    MDR report key: 1700332 · Received May 20, 2010

    Report

    Report Number
    2027969-2010-00614
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    April 28, 2010
    Report Date
    May 20, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE NEGATIVE D-DIMER RESULT ON TRIAGE D-DIMER TEST KIT. CALLER SAID, THE PATIENT WAS ADMITTED ON (B)(6)2010 WITH FEBRILE ILLNESS AND WAS ADMITTED. THE D-DIMER SAMPLE WAS TAKEN THE FOLLOWING DAY. IT WAS A SHORT DRAW AND HARDLY ANY PLASMA WAS AVAILABLE TO RUN THE D-DIMER TEST AFTER SAMPLE WAS SPUN DOWN. THE WHOLE BLOOD RESULT WAS BELOW CUTOFF AND THE REPEAT TEST WITH THE PLASMA GAVE A POSITIVE RESULT. NO ACTION WAS TAKEN AND PATIENT WAS WATCHED FOR A FEW DAYS AND THEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-DIMER 25 TEST KIT CARDIAC MARKER TEST GHH BIOSITE INCORPORATED 98100 W46010

    Patients

    Seq Age Sex Outcome Treatment
    1