BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 7085393 · Received December 5, 2017

    Report

    Report Number
    2024674-2017-00004
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 5, 2017
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62838RB. NO ISSUES WITH ANALYSE 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 INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2017: PATIENT CAME TO PHYSICIAN DUE TO PAIN IN LEFT LEG. TRIAGE D-DIMER RESULT WAS 1240NG/ML. THE PATIENT WAS TREATED WITH BLOOD THINNER, LIXIANA AND COMPRESSION. CUSTOMER IS NOT QUESTIONING THIS DATA, ONLY PROVDED AS HISTORICAL INFORMATION.ON (B)(6) 2017: PATIENT CAME BACK TO PHYSICIAN WITH PAIN IN LEFT LEG. TRIAGE D-DIMER RESULT WAS 1050NG/ML. DUE TO THIS RESULT, PATIENT WAS TRANSFERRED TO ANGIOGRAPHGY INSTITUE FOR VERIFICATION. A CT SCAN WAS PERFORMED. NO DEEP VEIN THROMBOSIS WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863752 TRIAGE D-DIMER PANEL D-DIMER: FIBRIN SPLIT PRODUCTS GHH QUIDEL CARDIOVASCULAR INC. 98100EU W62838RB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other