BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 22091178 · Received May 27, 2025

    Report

    Report Number
    3005094123-2025-00257
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    February 16, 2016
    Report Date
    July 16, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: PATIENT 1, PATIENT 2. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, ALINITY I STAT HIGH SENSITIVITY TROPONIN-I, LIST NUMBER 0421, WITH 510K/PMA/BLA NUMBER K202525. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    (B)(6). THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A FIELD DATA REVIEW, AND A LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I STAT HIGH SENSITIVE 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 70016UD00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 70016UD00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENTS IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE MEDIAN PATIENT RESULT FOR LOT 70016D00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. 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 70016UD00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR TWO PATIENTS, WHICH WERE INCONSISTENT WITH THE NEGATIVE SCANS. ADDITIONAL INFORMATION REGARDING THE SCANS WAS REQUESTED, BUT THE CUSTOMER DOES NOT HAVE ANY FURTHER DETAILS TO PROVIDE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: =/<2 NG/L PATIENT 1: ON (B)(6) 2025 13:53 TROPONIN RESULT = 332 NG/L, ON (B)(6) 2025 11:07 TROPONIN RESULT = 364 NG/L, ON (B)(6) 2024 20:34 TROPONIN RESULT = 239 NG/L, ON (B)(6) 2024 08:50 TROPONIN RESULT = 291. NG/L, ON (B)(6) 2024 20:07 TROPONIN RESULT = 283 NG/L, ON (B)(6) 2024 04:41 TROPONIN RESULT = 255. NG/L, ON (B)(6) 2024 13:42 TROPONIN RESULT = 293 NG/L, ON (B)(6) 2024 20:13 TROPONIN RESULT = 339. NG/L, ON (B)(6) 2024 15:17 TROPONIN RESULT = 316 NG/L, ON (B)(6) 2024 10:43 TROPONIN RESULT = 194. NG/L, ON (B)(6) 2024 18:12 TROPONIN RESULT = 215 NG/L, ON (B)(6) 2024 12:07 TROPONIN RESULT = 215. NG/L, ON (B)(6) 2024 14:01 TROPONIN RESULT = 247 NG/L, ON (B)(6) 2024 21:07 TROPONIN RESULT = 279. NG/L, ON (B)(6) 2024 14:44 TROPONIN RESULT = 285 NG/L, ON (B)(6) 2019 19:56 TROPONIN RESULT = 84 NG/L, ON (B)(6) 2019 16:46 TROPONIN RESULT = 82 NG/L, ON (B)(6) 2018 20:20 TROPONIN RESULT = 81 NG/L, ON (B)(6) 2018 22:58 TROPONIN RESULT = 73 NG/L, ON (B)(6) 2018 19:43 TROPONIN RESULT = 79 NG/L, ON (B)(6) 2018 16:44 TROPONIN RESULT = 59 NG/L, ON (B)(6) 2018 13:35 TROPONIN RESULT = 55 NG/L, ON (B)(6) 2016 08:00 TROPONIN RESULT = 23 NG/L, ON (B)(6) 2016 13:43 TROPONIN RESULT = 17 NG/L, ON (B)(6) 2016 10:18 TROPONIN RESULT = 24 NG/L. PATIENT 2: ON (B)(6) 2024 12:54 TROPONIN RESULT = 116 NG/L, ON (B)(6) 2024 13:45 TROPONIN RESULT = 77 NG/L, ON (B)(6) 2024 10:46 TROPONIN RESULT = 73 NG/L , THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR TWO PATIENTS, WHICH WERE INCONSISTENT WITH THE NEGATIVE SCANS. ADDITIONAL INFORMATION REGARDING THE SCANS WAS REQUESTED, BUT THE CUSTOMER DOES NOT HAVE ANY FURTHER DETAILS TO PROVIDE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: =/<2 NG/L. PATIENT 1: (B)(6) 2025 13:53 TROPONIN RESULT = 332 NG/L. (B)(6) 2025 11:07 TROPONIN RESULT = 364 NG/L. (B)(6) 2024 20:34 TROPONIN RESULT = 239 NG/L. (B)(6) 2024 08:50 TROPONIN RESULT = 291 NG/L. (B)(6) 2024 20:07 TROPONIN RESULT = 283 NG/L. (B)(6) 2024 04:41 TROPONIN RESULT = 255 NG/L. (B)(6) 2024 13:42 TROPONIN RESULT = 293 NG/L. (B)(6) 2024 20:13 TROPONIN RESULT = 339 NG/L. (B)(6) 2024 15:17 TROPONIN RESULT = 316 NG/L. (B)(6) 2024 10:43 TROPONIN RESULT = 194 NG/L. (B)(6) 2024 18:12 TROPONIN RESULT = 215 NG/L. (B)(6) 2024 12:07 TROPONIN RESULT = 215 NG/L. (B)(6) 2024 14:01 TROPONIN RESULT = 247 NG/L. (B)(6) 2024 21:07 TROPONIN RESULT = 279 NG/L. (B)(6) 2024 14:44 TROPONIN RESULT = 285 NG/L. (B)(6) 2019 19:56 TROPONIN RESULT = 84 NG/L. (B)(6) 2019 16:46 TROPONIN RESULT = 82 NG/L. (B)(6) 2018 20:20 TROPONIN RESULT = 81 NG/L. (B)(6) 2018 22:58 TROPONIN RESULT = 73 NG/L. (B)(6) 2018 19:43 TROPONIN RESULT = 79 NG/L. (B)(6) 2018 16:44 TROPONIN RESULT = 59 NG/L. (B)(6) 2018 13:35 TROPONIN RESULT = 55 NG/L. (B)(6) 2016 08:00 TROPONIN RESULT = 23 NG/L. (B)(6) 2016 13:43 TROPONIN RESULT = 17 NG/L. (B)(6) 2016 10:18 TROPONIN RESULT = 24 NG/L. PATIENT 2: (B)(6) 2024 12:54 TROPONIN RESULT = 116 NG/L. (B)(6) 2024 13:45 TROPONIN RESULT = 77 NG/L. (B)(6) 2024 10:46 TROPONIN RESULT = 73 NG/L . THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715150 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 70016UD00 00380740160647

    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).