BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER 25 TEST KIT

    MDR report key: 2238309 · Received September 1, 2011

    Report

    Report Number
    2027969-2011-01913
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT TESTED 2 POS CONTROLS ON D-DIMER LOT W48148. NO LOW BIAS, FALSE NEGATIVES OR DISCREPANT RESULTS WERE OBSERVED WITH EITHER SAMPLE. NO SAMPLE WAS RETURNED BY THE CUSTOMER. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE OR ENVIRONMENTAL FACTOR THAT IS KNOWN TO AFFECT ANALYTE RECOVERY. CUSTOMER RE-RAN ELEVATED SAMPLE AND RECEIVED THE SAME RESULT. SECOND SAMPLE FROM (B)(6) 2011 WAS RE-RAN AND THE SAME RESULT WAS OBTAINED. NO PRODUCT DEFICIENCY WAS ESTABLISHED. AS OF (B)(6) 2011 THERE ARE 2 COMPLAINTS ON D-DIMER LOT W48148. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE D-DIMER RESULTS. RESULTS AS FOLLOWS: PT PRESENTED (B)(6) 2011 WITH BILATERAL SHOULDER PAIN WHEN BREATHING, SHORTNESS OF BREATH, CARDIOMYOPATHY AND A HEART MURMUR. PT CAME BACK FOR A FOLLOW UP ON (B)(6) 2011. ON (B)(6) 2011- PT WAS GIVEN AN ECHO CARDIOGRAM, AND THE FOLLOWING MEDICATIONS: DEPOMEDROL AND DECADRON. ESTABLISHED REFERENCE RANGE: 400NG/ML. OTHER TUBES FROM RAINBOW DRAW HAD NO EVIDENCE OF HEMOLYSIS, LIPEMIA, NOR WERE ICTERIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-DIMER 25 TEST KIT CARDIAC TEST GHH ALERE SAN DIEGO INC. 98100 W48148B

    Patients

    Seq Age Sex Outcome Treatment
    1