BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 7820858 · Received August 27, 2018

    Report

    Report Number
    3013982035-2018-00024
    Event Type
    Injury
    Date Received
    August 27, 2018
    Report Date
    August 27, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR, INC.
    Product Code
    DAP
    PMA / PMN Number
    K080269
    Adverse Event
    Yes
    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 W64210RB. 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 (97300EU) IS NOT APPROVED IN THE UNITED STATES, THIS 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 CALLED IN STATING THEY RECEIVED A LATE DELIVERY OF TRIAGE SOB DEVICES. THE PRODUCT WAS IN TRANSIT FOR FOUR DAYS. THE CUSTOMER WAS NOT INFORMED OF THE DELAY IN DELIVERY UNTIL AFTER TESTING WAS PERFORMED ON A PATIENT. DETAILS OF THE PATIENT TESTING ARE AS FOLLOWS: PATIENT PRESENTED WITH RIGHT THORAX PAIN (PREVIOUSLY INPATIENT IN UROLOGY). THE PATIENT WAS TESTED ON TRIAGE AND YIELDED A D-DIMER OF 1430NG/ML. IN ADDITION TO THE ELEVATED D-DIMER RESULT, INFECTION PARAMETERS WERE ALSO INCREASED WITH THE PATIENT (CRP, LEUKOS, AND BSG). PATIENT WAS STARTED ON ANTIBIOTIC THERAPY. A CT OF THE THORAX AND PULMONARY SCINTIGRAPHY WAS ORDERED FOR THE PATIENT. NO LEFT ATRIUM ENLARGEMENT (LAE) IDENTIFIED. THE DOCTOR FELT THE INCREASED D-DIMER WAS DUE TO THE INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660273 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL DAP QUIDEL CARDIOVASCULAR, INC. 97300EU W64210B

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other