BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVITY TROPONIN-I

    MDR report key: 16478799 · Received March 3, 2023

    Report

    Report Number
    3005094123-2023-00056
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 12, 2023
    Report Date
    April 18, 2023
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    UDI-DI
    00380740194062
    PMA / PMN Number
    K202525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I STAT HIGH SENSITIVITY TROPONIN-I, LIST NUMBER 04Z21-25, AND MANUFACTURING SITE IN SECTION D OF THIS REPORT LONGFORD TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, AND MANUFACTURING SITE OF NEW SUSPECT DEVICE IRVING, TX. MDR NUMBER 3016438761-2023-00215-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I HIGH SENSITIVE TROPONIN RESULTS FOR ONE 81 YEAR OLD FEMALE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT 140 NG/L, RERUN ON SAME ANALYZER 4.9 NG/L, RERUN ON OTHER ANALYZER 4.5 NG/L (CUSTOMER NORMAL RANGE FOR FEMALE 21 YEARS OLD AND OLDER IS <14 NG/L). CUSTOMER RAN SPECIMEN ON THEIR OTHER ANALYZER AND THAT RESULTED WITH 4.6 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871589 ALINITY I STAT HIGH SENSITIVITY TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 04Z2125 45194UD00 00380740194062

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)