BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE PROFILER SOB PANEL (25T)

    MDR report key: 7207472 · Received January 19, 2018

    Report

    Report Number
    3013982035-2018-00002
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 19, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    DAP
    PMA / PMN Number
    K080269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W63103B. NO MEASUREMENT FAILURES WERE OBSERVED AND THE PRODUCT PERFORMED AS EXPECTED. MANUFACTURING BATCH RECORDS FOR LOT W63103B WERE REVIEWED AND FOUND THE LOT MET FINAL RELEASE SPECIFICATIONS AND SHOWED NO MEASUREMENT FAILURES AT FINAL RELEASE. A DEVICE DEFICIENCY CANNOT BE SUBSTANTIATED. 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

    THE CUSTOMER REPORTED RECEIVING TWO MEASUREMENT FAILURE ERROR MESSAGES WHILE TESTING A PATIENT SAMPLE ON THE TRIAGE METER SN (B)(4) AND TRIAGE PROFILER SOB PANEL LOT NUMBER W63103B. THE CUSTOMER STATED THERE WAS A WHITE COATING ON THE EDTA BLOOD SAMPLE. THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE SAMPLE AND ATTEMPT TO TEST AGAIN USING PLASMA. HOWEVER, WHILE THE SAMPLE WAS IN THE CENTRIFUGE, THE PATIENT WAS RUSHED TO THE HOSPITAL WITH SUSPICION OF PULMONARY EMBOLISM (PE). THE CUSTOMER STATED THAT THE PATIENT'S SYMPTOMS BECAME MORE SEVERE WHILE ATTEMPTING TO OBTAIN VALID TRIAGE RESULTS. THE MEASUREMENT FAILURES MAY HAVE CAUSED A DELAY IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50678 TRIAGE PROFILER SOB PANEL (25T) CARDIOPROFILER PANEL DAP QUIDEL CARDIOVASCULAR INC. 97300EU W63103B

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization