BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS TNI PANEL

    MDR report key: 11579623 · Received March 27, 2021

    Report

    Report Number
    3013982035-2021-00006
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    September 14, 2020
    Report Date
    February 25, 2021
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMERS REPORTED COMPLAINT LOT, T11471RN, EXPIRED JANUARY 3, 2021. ON MARCH 26, 2021, RETAINS OF THE EXPIRED COMPLAINT LOT WERE TESTED IN-HOUSE, NO ISSUES WITH TNI RECOVERY WERE OBSERVED. CUSTOMER'S COMPLAINT WAS NOT REPLICATED, THE LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR LOT T11471RN 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTS WHEN CONFIRMING TROPONINI (TNI) RESULTS FOR A CORRELATION STUDY BETWEEN THE TRIAGE METER AND VITROS DISCREPANT RESULTS WERE OBSERVED. SAMPLE 1- VIRTOS: 0.194 NG/ML TRIAGE: <0.05 NG/ML. SAMPLE 2- VIRTOS: 0.062 NG/ML TRIAGE: <0.05 NG/ML. TNI CUT OFF VALUE IS >0.012 NG/ML FOR VITROS AND >0.05 NG/ML FOR TRIAGE. NO MEDICAL DECISIONS WERE MADE BASED ON THE TRIAGE RESULTS. CUSTOMER STATED THE TRIAGE METER IS NOT BEING USED FOR PATIENT RESULTS, THEY ARE ATTEMPTING TO PERFORM A VALIDATION TO IMPLEMENT THE METER. NO ADDITIONAL PATIENT INFORMATION COULD BE PROVIDED. CUSTOMER REPORTED THEIR TRIAGE METER PASSED QCD DEVICE AND CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475861 TRIAGE CARDIAC HS TNI PANEL TRIAGE CARDIAC HS TNI PANEL MMI QUIDEL CARDIOVASCULAR INC. 97021HS T11471RN

    Patients

    Seq Age Sex Outcome Treatment
    1