BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS PANEL

    MDR report key: 11932596 · Received June 3, 2021

    Report

    Report Number
    3013982035-2021-00011
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 3, 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 T12165N. 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 T12165N 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIGH TROPONINI (TNI) ON TRIAGE WITH ONE PATIENT. ON (B)(6) 2021, (B)(6)-YEAR-OLD MALE PATIENT PRESENTED TO EMERGENCY CENTER WITH HYPERTENSION. INITIAL TRIAGE TEST (DRAWN (B)(6) 2021 7:50AM), TNI = 0.13. RE-DRAW (NO TIME PROVIDED BUT DRAW ON SAME DAY, TEST WAS ORDERED AT 8:56AM, RESULTED AT 10:00AM), RESULTED IN AN ERROR CODE, E1. SAME RE-DRAW SAMPLE REPEAT TESTING, TNI = 0.05. REFERENCE RANGE: 0.0-0.05, CRITICAL (TEST TO BE REPEATED): >/= 0.06. CONFIRMATORY TESTING (POSSIBLY FROM 2ND DRAW USED) TNI = 0.012 (METHOD/INSTRUMENT NOT PROVIDED, REFERENCE RANGE: 0.012-0.033). EKG WAS NORMAL. PATIENT NOT DIAGNOSED WITH MI AND PATIENT NOT ADMITTED. NO PROCEDURAL ISSUES IDENTIFIED. MYO LAB RESULTS: INITIAL=259, RE-DRAW, REPEAT=220.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831320 TRIAGE CARDIAC HS PANEL TRIAGE CARDIAC HS PANEL MMI QUIDEL CARDIOVASCULAR INC. 97000HS T12165N

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR TRIAGE METERPRO, PN: 55070, SN: (B)(4)