BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24446335 · Received February 25, 2026

    Report

    Report Number
    3005094123-2026-00095
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 23, 2026
    Report Date
    April 9, 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. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13-24 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K NUMBER K202525.

    Additional Manufacturer Narrative · 0

    THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 81020UD00; HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I ASSAY (LIST NUMBER 08P13). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON CONFORMANCES, OR DEVIATIONS WITH LOT 81020UD00 AND THE COMPLAINT ISSUE. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT OF THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER¿S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT, LOT NUMBER 81020UD00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE MALE PATIENT WHEN COMPARED TO RESULTS FROM ANOTHER METHOD (AFIAS). PATIENT BACKGROUND: REGULAR MONITORING OF IMMUNOTHERAPY FOR MELANOMA, ECG WAS NORMAL. THE FOLLOWING DATA WAS PROVIDED: FIRST SAMPLE FROM (B)(6) 2026 (07:58), SID (B)(6), ALINITY ((B)(6) RESULTS 80.9 / 78.9 NG/L (LOT 81020UD00) (CUTOFF <16 NG/L). SECOND SAMPLE OBTAINED ON (B)(6) 2026 (19:45) (SID UNKNOWN) AFIAS RESULT WAS 20 NG/L (CUTOFF <30 NG/L) THE FIRST SAMPLE (SID (B)(6) WAS REPEATED ON (B)(6) 2026 (15:19) ON ALINITY (B)(6) AND THE RESULTS WERE 52.4 / 63.4 NG/L. THIRD SAMPLE WAS OBTAINED ON (B)(6) 2026 (15:47) SID (B)(6) , ALINITY (B)(6) RESULTS 9.2 NG/L (LOT 81564UD00), AND (B)(6) 2026 (11:51) ALINITY (B)(6) RESULT 11 NG/L (LOT 81564UD00). THIRD SAMPLE (SID (B)(6) WAS REPEATED WITH AFIAS AND THE RESULT WAS 10 NG/L. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE MALE PATIENT WHEN COMPARED TO RESULTS FROM ANOTHER METHOD (AFIAS). PATIENT BACKGROUND: REGULAR MONITORING OF IMMUNOTHERAPY FOR MELANOMA, ECG WAS NORMAL. THE FOLLOWING DATA WAS PROVIDED: FIRST SAMPLE FROM (B)(6) 2026 (07:58), SID (B)(6), ALINITY (B)(6) RESULTS 80.9 / 78.9 NG/L (LOT 81020UD00) (CUTOFF <16 NG/L). SECOND SAMPLE OBTAINED ON (B)(6) 2026 (19:45) (SID UNKNOWN) AFIAS RESULT WAS 20 NG/L (CUTOFF <30 NG/L) THE FIRST SAMPLE (SID (B)(6) WAS REPEATED ON (B)(6)2026 (15:19) ON ALINITY (B)(6) AND THE RESULTS WERE 52.4 / 63.4 NG/L. THIRD SAMPLE WAS OBTAINED ON (B)(6) 2026 (15:47) SID(B)(6), ALINITY (B)(6) RESULTS 9.2 NG/L (LOT 81564UD00), AND (B)(6) 2026 (11:51) ALINITY (B)(6) RESULT 11 NG/L(LOT 81564UD00). THIRD SAMPLE (SID (B)(6) WAS REPEATED WITH AFIAS AND THE RESULT WAS 10 NG/L. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382980 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 81020UD00 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1