BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFLER SOB PANEL

    MDR report key: 9433342 · Received December 6, 2019

    Report

    Report Number
    3013982035-2019-00033
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 6, 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 CUSTOMERS COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAINS OF LOT T10556N. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT T10556N 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, 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 REPORTED ELEVATED TRIAGE D-DIMER RESULTS. ON (B)(6) 2019, THE LAB RECEIVED A WHOLE BLOOD PATIENT SAMPLE FROM THE DOCTOR. SAMPLE WAS TESTED ON TRIAGE AND YIELDED AN ELEVATED D-DIMER OF 2170NG/ML. THE LAB INFORMED THE DOCTOR OF THE PATIENTS RESULT. PATIENT WAS SENT TO THE HOSPITAL ON (B)(6) 2019. THE HOSPITAL RAN A D-DIMER TEST AND RECEIVED AN ELEVATED D-DIMER OF 3.3. METHOD AND UNITS OF THE HOSPITAL TEST ARE UNKNOWN. THE LAB RECEIVED AN ADDITIONAL SAMPLE FROM THE PATIENT ON (B)(6) 2019 AND TESTED ON TRIAGE AGAIN. ELEVATED D-DIMER OF 2070NG/ML WAS RECEIVED. PATIENT HAD NO DEEP VEIN THROMBOSIS NOR LUNG EMBOLISM. THE PATIENT HAS A LOT OF METASTASIS AND FINAL DIANGOSIS WAS CANCER. TRIAGE D-DIMER CUT-OFF: 400NG/ML. HOSPITAL D-DIMER CUT-OFF: 0.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224528 TRIAGE PROFLER SOB PANEL TRIAGE PROFLER SOB PANEL DAP QUIDEL CARDIOVASCULAR INC. 97300EU T10556N

    Patients

    Seq Age Sex Outcome Treatment
    1