BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 21257068 · Received January 28, 2025

    Report

    Report Number
    3005094123-2025-00041
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 20, 2025
    Report Date
    February 20, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740186029
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 SENSITIVE TROPONIN-I, 08P13, LONGFORD MANUFACTURING SITE TO ALINITY I PROCESSING MODULE, 03R65, IRVING IA/CC MANUFACTURING SITE. MDR NUMBER 3016438761-2025-00113 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 REPORTED A FALSE POSITIVE ALINITY STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE PATIENT GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 46 NG/L REPEAT RESULT = 3.8 NG/L REPEAT RESULT ON ANOTHER MODULE = 3.8 NG/L. NO CUSTOMER CUTOFF WAS PROVIDED FOR ALINITY I STAT HIGH SENSITIVE TROPONIN-I, THEREFORE USING THE PACKAGE INSERT OVERALL CUT OFF OF 26.2 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE PATIENT GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL RESULT = 46 NG/L, REPEAT RESULT = 3.8 NG/L, REPEAT RESULT ON ANOTHER MODULE = 3.8 NG/L. NO CUSTOMER CUTOFF WAS PROVIDED FOR ALINITY I STAT HIGH SENSITIVE TROPONIN-I, THEREFORE USING THE PACKAGE INSERT OVERALL CUT OFF OF 26.2 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377255 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 68456UD00 00380740186029

    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)