BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 8588876 · Received May 7, 2019

    Report

    Report Number
    3013982035-2019-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 7, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    DAP
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W64982N. 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 (97300EUA) 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

    EVENT OCCURRED IN (B)(6). CUSTOMER REPORTED DISCREPANT LOW D-DIMER RESULTS FOR 1 PATIENT. PATIENT 2: NORMAL TRIAGE D-DIMER = 107 NG/ML. ULTRASOUND CONFIRMED DEEP VEIN THROMBOSIS. CUSTOMER'S TRIAGE D-DIMER CUTOFF- 400 NG/ML. CUSTOMER STATED NO TREATMENT WAS WITHHELD BASED ON TRIAGE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381309 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL DAP QUIDEL CARDIOVASCULAR INC. 97300EUA W64982N

    Patients

    Seq Age Sex Outcome Treatment
    1