BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 21363297 · Received February 12, 2025

    Report

    Report Number
    3005094123-2025-00071
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 24, 2025
    Report Date
    February 12, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 K042924. THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I STAT HIGH SENSITIVITY TROPONIN-I ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 65189UD00. DEVICE HISTORY RECORD REVIEW FOR LOT 65189UD00 DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN POPULATION RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I STAT HIGH SENSITIVITY TROPONIN-I ASSAY FOR LOT 65189UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE < 26.2 PG/ML) INITIAL RESULT = 3000-4000 PG/ML, SO THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL. BLOOD WAS TAKEN AGAIN AT THE OTHER HOSPITAL TEST ON UNKNOWN METHOD = 0.92NG/ML, RETEST RESULT = 0.6 NG/ML (EQUIVALENT VALUE 920 PG/ML, 600 PG/ML). THE CUSTOMER REPORTED OTHER TESTS WERE PERFORMED, POSSIBLY EKG OR ECHOCARDIOGRAM, SHOWING NO EVIDENCE OF CARDIAC ABNORMALITIES. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042061 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 65189UD00 00380740160630

    Patients

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