BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24400172 · Received February 20, 2026

    Report

    Report Number
    3005094123-2026-00086
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    DURING A CORRELATION STUDY, THE CUSTOMER OBSERVED ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS ON A PATIENT WHEN COMPARED TO OTHER METHODS (ROCHE AND AFIAS). THE ALINITY RESULTS HAD BEEN PREVIOUSLY REPORTED AND ARCHIVED. FOR THIS STUDY, THE ARCHIVED SAMPLES WERE TESTED USING THE SERVIBIO AFIAS (POINT-OF-CARE TESTING) TECHNIQUE AND ROCHE ELECSYS TROPONIN. THE FOLLOWING DATA WAS PROVIDED: 70-YEAR-OLD FEMALE, SID: (B)(6), PATIENT BACKGROUND: CARDIAC DECOMPENSATION, DILATED CARDIOMYOPATHY (BNP = 1553 ON (B)(6) 2026). ALINITY (SN: (B)(6). ON (B)(6) 2026 92 / 90 NG/L. ON (B)(6) 2026 120 NG/L. ON (B)(6) 2026 96 NG/L. ON (B)(6) 2026 88 NG/L. ALINITY (SN: (B)(6): ON (B)(6) 2026 110 NG/L. AFIAS SERVBIO 25 NG/L. ROCHE ELECSYS 160 NG/L. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541700 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 81564UD00 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6).