BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 9468721 · Received December 13, 2019

    Report

    Report Number
    3013982035-2019-00035
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 13, 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 T10741N. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT T10741N 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 FOR ONE PATIENT. TRIAGE PRODUCED THE FOLLOWING RESULTS: 3970NG/ML, 1310NG/ML AND >5000NG/ML. PATIENT RECEIVED A CT SCAN. RESULTS OF THE SCAN WERE "NEGATIVE". ALTHOUGH REQUESTED, NO ADDITIONAL DETAILS WERE PROVIDED AROUND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260202 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL DAP QUIDEL CARDIOVASCULAR INC. 97300EU T10741N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other