BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS PANEL

    MDR report key: 11933358 · Received June 3, 2021

    Report

    Report Number
    3013982035-2021-00012
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    April 18, 2021
    Report Date
    May 4, 2021
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 T11877N. RETAINS OF THE COMPLAINT LOT PERFORMED PROPERLY WHEN TESTED WITH "NORMAL" (APPARENTLY HEALTHY) DONORS; ALL TNI RESULTS <0.05NG/ML. MANUFACTURING BATCH RECORDS FOR LOT T11877N 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 HIGH TROPONINI (TNI) ON TRIAGE WITH ONE PATIENT. ON (B)(6) 2021, (B)(6) FEMALE PATIENT PRESENTED TO EMERGENCY CENTER WITH COVID SYMPTOMS. (B)(6). EKG ABNORMAL: POSSIBLE RIGHT VENTRICULAR CONDUCTION DELAY. PATIENT REFERRED TO CARDIOLOGIST. NO INVASIVE PROCEDURES PERFORMED; PATIENT NOT TREATED ON TRIAGE RESULT. PATIENT WAS ADMITTED DUE TO ELEVATED TNI. DISCHARGE DIAGNOSIS: CORONAVIRUS INFECTION UNSPECIFIED, ELEVATED TNI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826008 TRIAGE CARDIAC HS PANEL TRIAGE CARDIAC HS PANEL MMI QUIDEL CARDIOVASCULAR INC. 97000HS T11877N

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR TRIAGE METERPRO, PN: 55070, SN: (B)(4)