BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 9079743 · Received September 17, 2019

    Report

    Report Number
    3013982035-2019-00020
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    July 28, 2019
    Report Date
    September 17, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    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 T10098RN. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT T10098RN 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

    THE CUSTOMER REPORTED A PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SUSPECT OF PULMONARY EMBOLISM. PATIENT WAS TESTED ON TRIAGE AND RESULTED WITH AN ABNORMAL D-DIMER RESULT OF 1480NG/ML. PATIENT WAS ADMITTED. PATIENT SAMPLE SENT TO THE LAB WHERE NYCOCARD PROVIDED A NORMAL D-DIMER RESULT OF 0.1MG/L. PATIENT WAS DISCHARGED WITH NO PE DIAGNOSIS. SITES NYCOCARD CUT-OFF IS 0.3MG/L; SITES TRIAGE D-DIMER CUT-OFF IS 600NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871367 TRIAGE D-DIMER PANEL TRIAGE D-DIMER PANEL GHH QUIDEL CARDIOVASCULAR INC. 98100EU T10098RN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR