BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24634022 · Received March 18, 2026

    Report

    Report Number
    3005094123-2026-00133
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K/PMA/BLA NUMBER K202525.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE FEMALE PATIENT. THE RESULT WAS NOT REPORTED. THE SAMPLE WAS REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL HSTNI RESULT PROCESSED ON ALINITY I SERIAL NUMBER (B)(6) = 204.7 PG/ML REPEAT RESULTS = <3.7 PG/ML AND <3.7 PG/ML PROCESSED ON TWO ALINITY I SERIAL NUMBERS (B)(6) AND (B)(6). OTHER RESULT PROVIDED CK-MB = <1.00. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694990 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 80170UD00 00380740160647

    Patients

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