BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 21265166 · Received January 29, 2025

    Report

    Report Number
    3005094123-2025-00043
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 30, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21, WITH 510K/PMA/BLA NUMBER K202525.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I STAT HIGH SENSITIVE TROPONIN-I, LIST 08P13-34 AND MANUFACTURING SITE IN SECTION D OF THIS REPORT LONGFORD, TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, AND MANUFACTURING SITE OF IRVING, TEXAS. MDR NUMBER 3016438761-2025-00090 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT 106.2 NG/L RESULTS FROM NEW SAMPLE 0.0 NG/L REPEAT FIRST SAMPLE 0.0 NG/L. THE PHYSICIAN ADMITTED THE PATIENT TO THE EMERGENCY AND THAT¿S WHERE THEY PERFORMED A NEW BLOOD DRAW THAT WAS NEGATIVE. NO NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT 106.2 NG/L RESULTS FROM NEW SAMPLE 0.0 NG/L REPEAT FIRST SAMPLE 0.0 NG/L. THE PHYSICIAN ADMITTED THE PATIENT TO THE EMERGENCY AND THAT¿S WHERE THEY PERFORMED A NEW BLOOD DRAW THAT WAS NEGATIVE. NO NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047393 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740160647

    Patients

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