BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24068743 · Received January 14, 2026

    Report

    Report Number
    3005094123-2026-00020
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 6, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740164157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 8P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, 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 REAGENT, LIST NUMBER 08P13-77, AND MANUFACTURING SITE: (B)(6) IRELAND TO ALINITY I PROCESSING MODULE, LIST NUMBER: 03R65-01, AND MANUFACTURING SITE OF ABBOTT LABORATORIES, (B)(6) TX. MDR NUMBER 3016438761-2026-00068 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED STAT HIGH SENSITIVE TROPONIN-I AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: SAMPLE ID (B)(6) INITIAL TEST WAS 0.061 NG/ML, RETEST RESULTS WERE 0.005 & 0.004 NG/ML (CUSTOMER REFERENCE RANGE: 0-0.016 NG/ML). PATIENT INFORMATION: 58-YEAR-OLD MALE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED STAT HIGH SENSITIVE TROPONIN-I AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: SAMPLE ID (B)(6) INITIAL TEST WAS 0.061 NG/ML, RETEST RESULTS WERE 0.005 & 0.004 NG/ML (CUSTOMER REFERENCE RANGE: 0-0.016 NG/ML). PATIENT INFORMATION: 58 YEAR OLD MALE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132703 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 82554UD01 00380740164157

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).