BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 7121925 · Received December 15, 2017

    Report

    Report Number
    2024674-2017-00007
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 15, 2017
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62880RB. NO ISSUES WITH ANALYE RECOVERY WERE OBSERVED AND THE PRODUCT PERFORMED AS EXPECTED. MANUFACTURING BATCH RECORDS WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATOIN OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED INFORMATION REGARDING THE FOLLOWING EVENT OCCURRING ON ONE PATIENT: PATIENT A (ALL RESULTS ON SAME PATIENT SAME DAY AND COLLECTION TIME, ONLY DIFFERENCE IS THAT PATHCARE DOES D-DIMER ON THE GREEN TOP TUBE HEPARINISED BLOOD) MAXI MEDICAL LAB TRIAGE D-DIMER - 875NG/ML (REFERENCE RANGE < 500NG/ML) PATHCARE D-DIMER RESULT - 0.42UG/ML (REFERENCE RANGE < 0.5 UG/ML) CUSTOMER DID NOT KNOW THE METHODOLOGY PERFORMED AT PATHCARE SITE. THERE ARE NO CLINICAL DETAILS AVAILABLE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899858 TRIAGE D-DIMER PANEL FIBRIN SPLIT PRODUCTS, PRODUCT CODE: GHH GHH QUIDEL CARDIOVASCULAR INC. 98100EU W62880RB

    Patients

    Seq Age Sex Outcome Treatment
    1