BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 7794810 · Received August 17, 2018

    Report

    Report Number
    3013982035-2018-00023
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 17, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR, INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W63286RB. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED, LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED, LOT MET 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 DISCORDANT D-DIMER RESULTS FOR ONE PATIENT IN THE HOSPITAL. ON (B)(6) 2018 THE PATIENT YIELDED A TRIAGE D-DIMER OF 1660 NG/ML, CUSTOMER USING A CUT-OFF OF 600 NG/ML. THE PATIENT SAMPLE WAS SENT TO ANOTHER LAB AND TESTED FOR D-DIMER USING NYOCARD. D-DIMER WAS 0.3 MG/L, CUSTOMER USING A CUT-OFF OF 0.3 MG/L. ON (B)(6) 2018 THE CUSTOMER RETESTED THE PATIENT SAMPLE ON TRIAGE; D-DIMER WAS 1720 NG/ML. PATIENT WAS DIAGNOSED WITH VASOVAGAL SYNCOPE. PATIENT WAS NOT DIAGNOSED WITH DEEP VEIN THROMBOSIS OR PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635439 TRIAGE D-DIMER PANEL TRIAGE D-DIMER PANEL GHH QUIDEL CARDIOVASCULAR, INC. 98100EU W63286RB

    Patients

    Seq Age Sex Outcome Treatment
    1