BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER TEST

    MDR report key: 9147295 · Received October 2, 2019

    Report

    Report Number
    3013982035-2019-00022
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    August 25, 2019
    Report Date
    October 2, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT T10100RN. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT T10100RN WERE REVIEWED AND FOUND THAT THE LOT MET FINAL RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ALTHOUGH THIS CATALOG NUMBER (98100EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 98100, 510(K) NUMBER K042890.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TRIAGE D-DIMER RESULT NOT BEING CONSISTENT WITH PATIENT DIAGNOSIS. A YOUNG FEMALE PATIENT WAS TESTED ON TRIAGE AND RESULTED WITH A D-DIMER OF <100NG/ML. PHYSICIAN STATED PATIENT WAS CONFIRMED VIA ULTRASOUND TO HAVE A MUSCLE VT IN HER LOWER LEG. THERE WAS NO DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942281 TRIAGE D-DIMER TEST TRIAGE D-DIMER PANEL GHH QUIDEL CARDIOVASCULAR INC. 98100EU T10100RN

    Patients

    Seq Age Sex Outcome Treatment
    1