BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS TNI PANEL

    MDR report key: 14163930 · Received April 20, 2022

    Report

    Report Number
    3013982035-2022-00004
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 20, 2022
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAINED DEVICES OF LOT NUMBER T12759RN. DEVICES OF THE COMPLAINT LOT PERFORMED PROPERLY WHEN TESTING WITH A LOW LEVEL POSITIVE TNI CALIBRATOR, NO RESULTS <0.05NG/ML. MANUFACTURING BATCH RECORDS FOR LOT T12759RN 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

    TRIAGE CARDIAC HS TNI DISCREPANT LOW WHEN COMPARED TO SIEMENS EXL ON 4 PATIENT SAMPLES AND 7 TRIAGE DEVICES. THE CUSTOMER REPORTED 3 CRITICAL RESULTS AND 1 ABNORMAL RESULT PER THE SIEMENS INSTRUMENT THAT WHEN TESTED ON THE TRIAGE METERS INDICATED A RESULT <0.05 NG/ML. TESTING WAS PERFORMED FOR A TNI COMPARISON STUDY. UNKNOWN PATIENT OUTCOME, NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE TRIAGE RESULTS. TRIAGE UNITS ARE BEING IMPLEMENTED AS BACK UP ONLY. NO AE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227169 TRIAGE CARDIAC HS TNI PANEL TRIAGE CARDIAC HS TNI PANEL MMI QUIDEL CARDIOVASCULAR INC. 97021HS T12759RN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRIAGE METERPROS PN: 55071, SN: (B)(4), SN: (B)(4).