BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS TNI PANEL

    MDR report key: 11682511 · Received April 16, 2021

    Report

    Report Number
    3013982035-2021-00008
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Report Date
    March 18, 2021
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAIN DEVICE LOT T11640RN. RETAINS OF THE COMPLAINT LOT PERFORMED PROPERLY WHEN TESTED WITH A LOW LEVEL POSITIVE TNI CALIBRATOR. MANUFACTURING BATCH RECORDS FOR LOT T11640RN 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 · 1

    CUSTOMER REPORTED LOW TRIAGE TROPONINI(TNI) RESULT COMPARED TO ARCHITECT AND ISTAT. TRIAGE TNI = <0.05, NEGATIVE. ARCHITECT = 0.141, POSITIVE. AND ISTAT = 0.13, POSITIVE. PATIENT DIAGNOSIS WAS "TACHYCARDIA, A. FIB" CUTOFF VALUES: TRIAGE > 0.04 NG/ML = ABNORMAL, ISTAT > 0.08 NG/ML = ABNORMAL, ARCITECT > 0.06 NG/ML = ABNORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576964 TRIAGE CARDIAC HS TNI PANEL TRIAGE CARDIAC HS TNI PANEL MMI QUIDEL CARDIOVASCULAR INC. 97021HS T11640RN

    Patients

    Seq Age Sex Outcome Treatment
    1