BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE TRIAGE D-DIMER TEST

    MDR report key: 5813873 · Received July 21, 2016

    Report

    Report Number
    2027969-2016-00530
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 23, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PATIENT SAMPLE YIELDED D-DIMER RESULTS CLOSE TO THE CUSTOMER'S OBSERVED <100 NG/ML WHEN TESTED IN-HOUSE WITH RETAIN LOT W60947. CUSTOMER'S COMPLAINT OF DISCREPANT LOW WAS REPLICATED. CUSTOMER'S COMPLAINT OF DISCREPANT LOW WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W60947 AND CARDIAC MARKER CALIBRATOR D. RESULTS WERE FOUND TO BE WITHIN THE PACKAGE INSERT CLAIM. CUSTOMER'S COMPLAINT OF DISCREPANT LOW WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W60947 AND D-DIMER ELEVATED DONOR WHOLE BLOOD. RESULTS WERE POSITIVE FOR D-DIMER. DEVICE LOT PERFORMED AS EXPECTED WITH IN-HOUSE SAMPLES, UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE WAS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. BATCH RECORDS FOR LOT W60947 WERE REVIEWED; LOT MET RELEASE SPECIFICATIONS; NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. NO PRODUCT DEFICIENCY WAS ESTABLISHED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A (B)(6) FEMALE CAME IN TO THE URGENT CARE REPORTING REDNESS/PURPLE DISCOLORATION TO GREAT TOE AND CALF. THE TRIAGE D-DIMER TEST RESULT WAS <100NG/ML (RANGE=0.500). THE PATIENT WENT ELSEWHERE TO OBTAIN AN ULTRASOUND WHICH INDICATED THAT THERE WAS A BLOOD CLOT. ON (B)(6) 2016 THE PATIENT RETURNED TO URGENT CARE AND THE TRIAGE D-DIMER TEST WAS REPEATED WITH THE SAME RESULT AS THE PREVIOUS DAY. THE PATIENT'S SAMPLE WAS SENT TO THE HOSPITAL FOR TESTING AND GAVE A RESULT OF 2.07 MCG/ML FEU (RANGE=0-0.5) ON THE STAGO COMPACT ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466940 ALERE TRIAGE D-DIMER TEST CARDIAC MARKER TEST GHH ALERE SAN DIEGO, INC. 98100 W60947B

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention