BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 11416728 · Received March 4, 2021

    Report

    Report Number
    3013982035-2021-00003
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 3, 2021
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    UDI-DI
    30014613337959
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAIN DEVICE LOT T11680N. RETAINS OF THE COMPLAINT LOT PERFORMED PROPERLY WHEN TESTED WITH "NORMAL" (APPARENTLY HEALTHY) DONORS. MANUFACTURING BATCH RECORDS FOR LOT T11680N 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 (97300EU) IS NOT APPROVED IN THE UNITED STATES, THE EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 97300, 510(K) NUMBER K080269.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT AFTER PULMONARY EMBOLISM WAS TESTED FOR D-DIMER ON TRIAGE AND RESULTED ABNORMAL AT 1250NG/ML. LAB RESULT WITH SAMPLE TAKEN AT THE SAME TIME AS TRIAGE RESULT WAS NORMAL AT 560UG/L. CUTOFF FOR TRIAGE: 400NG/ML, CUTOFF FOR LAB ANALYZER: 590UG/L. THE TIMING BETWEEN PULMONARY EMBOLISM DIAGNOSIS AND TRIAGE TESTING EVENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311184 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL GHH QUIDEL CARDIOVASCULAR INC. 97300EU T11680N 30014613337959

    Patients

    Seq Age Sex Outcome Treatment
    1