BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS TNI PANEL

    MDR report key: 11904918 · Received May 28, 2021

    Report

    Report Number
    3013982035-2021-00010
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Report Date
    April 29, 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 · 0

    INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAIN DEVICE LOT T11876N. RETAINS OF THE COMPLAINT LOT PERFORMED PROPERLY WHEN TESTED WITH A LOW LEVEL POSITIVE TNI CALIBRATOR, NO RESULTS <0.05NG/ML. MANUFACTURING BATCH RECORDS FOR LOT T11876N 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 CORRECTION ACTION IS REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DISCREPANCIES IN CORRELATION BETWEEN NEW TRIAGE METER AND ECI/VITROS. ECI 0.063. TRIAGE <0.05 ECI 0.068, TRIAGE <0.05 ECI 0.082, TRIAGE <0.05 ECI 0.096, TRIAGE <0.05 CUSTOMER USING TWO LOTS OF TRIAGE DEVICES. THIS MDR IS FOR TRIAGE LOT T11876N. MDR 3013982035-2021-00009 WAS FILED FOR LOT T11864RN. SITE CUT-OFF FOR ECI >0.012 SITE CUT-OFF FOR TRIAGE >0.05 CUSTOMER STATED NO MEDICAL DECISION WERE MADE ON TRIAGE RESULTS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797541 TRIAGE CARDIAC HS TNI PANEL TRIAGE CARDIAC HS TNI PANEL MMI QUIDEL CARDIOVASCULAR INC. 97021HS T11876N

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO, PN: 55070, SN: (B)(4)