BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 21185482 · Received January 17, 2025

    Report

    Report Number
    3005094123-2025-00022
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 10, 2024
    Report Date
    February 28, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 AND 510K/PMA/BLA K202525. SECTION A. PATIENT INFORMATION OF MULTIPLE IS FOR 2 PATIENTS. SID (B)(6) IS 51 YEAR OLD MALE, NO GENDER, RACE, ETHNICITY PROVIDED. SID (B)(6) IS 78 YEAR OLD MALE, NO GENDER, RACE, ETHNICITY PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4. CATALOG WAS UPDATED FROM 8P13-22 ON INITIAL SUBMISSION TO 8P13-37 ON FOLLOW-UP SUBMISSION. SECTION D4 PRIMARY UDI NUMBER WAS UPDATED TO (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21 AND 510K/PMA/BLA K202525. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4 EXPIRATION DATE WAS UPDATED TO 2/5/2025. PRIMARY UDI NUMBER WAS UPDATED TO (B)(4). THE COMPLAINT INVESTIGATION 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 DATA FOR ALINITY I STAT HIGH SENSITIVE TROPONIN-I ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, THE SIMILAR COMPLAINT TICKET SEARCH FOR LOT 67109UD00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF ALINITY I STAT HIGH SENSITIVE TROPONIN-I ASSAY AND LOT 67109UD00 USING WORLDWIDE DATA. THE REVIEW OF APPLICABLE FIELD DATA SHOWS PERFORMANCE DATA IS ACCEPTABLE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 67109UD00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I ON 2 PATIENT SAMPLES THAT REPEATED LOWER. ON 10DEC 2024, SID (B)(6) (51 YEAR OLD MALE) GENERATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I OF 746 NG/L (NEAT) BUT REPEATED LOWER <2 NG/L (HARD SPIN). ON (B)(6) 2025; SID (B)(6); (78 YEAR OLD MALE) GENERATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I OF 141.2 NG/L (NEAT) BUT REPEATED LOWER 3.8, 4.5, 4.1 NG/L (HARD SPIN). NO CUSTOMER TROPONIN CUTOFF WAS PROVIDED. NO GENDER, RACE, ETHNICITY WAS PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I ON 2 PATIENT SAMPLES THAT REPEATED LOWER. ON (B)(6) 2024, SID (B)(6) (51 YEAR OLD MALE) GENERATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I OF 746 NG/L (NEAT) BUT REPEATED LOWER <2 NG/L (HARD SPIN). ON (B)(6) 2025 SID (B)(6) (78 YEAR OLD MALE) GENERATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I OF 141.2 NG/L (NEAT) BUT REPEATED LOWER 3.8, 4.5, 4.1 NG/L (HARD SPIN). NO CUSTOMER TROPONIN CUTOFF WAS PROVIDED. NO GENDER, RACE, ETHNICITY WAS PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE ELEVATED ALINITY I STAT HIGHLY SENSITIVE TROPONIN-I ON 2 PATIENT SAMPLES THAT REPEATED LOWER. ON (B)(6) 2024, SID (B)(6) (51 YEAR OLD MALE) GENERATED ALINITY I STAT HIGHLY SENSITIVE TROPONIN-I OF 746 NG/L (NEAT) BUT REPEATED LOWER <2 NG/L (HARD SPIN). ON (B)(6) 2025 SID (B)(6) (78 YEAR OLD MALE) GENERATED ALINITY I STAT HIGHLY SENSITIVE TROPONIN-I OF 141.2 NG/L (NEAT) BUT REPEATED LOWER 3.8, 4.5, 4.1 NG/L (HARD SPIN). NO CUSTOMER TROPONIN CUTOFF WAS PROVIDED. NO GENDER, RACE, ETHNICITY WAS PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144955 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 67109UD00

    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).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).