BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVITY TROPONIN-I

    MDR report key: 17292227 · Received July 10, 2023

    Report

    Report Number
    3005094123-2023-00171
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 19, 2023
    Report Date
    August 8, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740194079
    PMA / PMN Number
    K202525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 04Z21-35, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND TO THE ALINITY I PROCESSING MODULE, LIST 03R65-01, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2023-00419-00 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.CORRECTION TO SECTION B: B3 - DATE OF EVENT: CORRECTED FROM 6/18/2023 TO 6/19/20223.

    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 STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE PATIENT WHO PRESENTED AT THE HOSPITAL WITH CHEST PAIN. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, AND THE RESULTS WERE LOWER. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0 TO 14 NG/L. SID 231706758A INITIAL RESULT = > 3600 NG/L; REPEAT RESULTS = 14, 15, 16 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805988 ALINITY I STAT HIGH SENSITIVITY TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 04Z2135 51288UD00 00380740194079

    Patients

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