BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVITY TROPONIN-I

    MDR report key: 18824973 · Received March 4, 2024

    Report

    Report Number
    3005094123-2024-00088
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 18, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740194079
    PMA / PMN Number
    K202525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, ACCURACY TESTING, AND DEVICE HISTORY RECORDS. RETURNS WERE NOT AVAILABLE. THE REVIEW OF HISTORICAL PERFORMANCE OF REAGENT LOT 58191UD00, WAS COMPLETED. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 58191UD00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. ACCURACY OF THE ASSAY HAS BEEN EVALUATED WITH A RETAINED IN-HOUSE KIT AND MET ALL SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I PRODUCT REQUIREMENTS. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, THE ALINITY I STAT HIGH SENSITIVITY TROPONIN-I LOT NUMBER 58191UD00 IDENTIFIED NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT ON A FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 03:58 PM SID (B)(6) 184.3 NG/L, REPEATED SAME SAMPLE ON ANOTHER ALINITY ON (B)(6) 2024 = < 4 NG/K; NEW SAMPLE ON (B)(6) 2024 17:10 SID (B)(6) = < 4 NG/L. NEW SAMPLE ON (B)(6) 2024 18:26 SID (B)(6) = < 4 NG/L. REFERENCE RANGE: FEMALE <13 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT ON A FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024 03:58 PM SID (B)(6) 184.3 NG/L, REPEATED SAME SAMPLE ON ANOTHER ALINITY ON (B)(6) 2024 = < 4 NG/K. NEW SAMPLE ON (B)(6) 2024 17:10 SID (B)(6) = < 4 NG/L. NEW SAMPLE ON (B)(6) 2024 18:26 SID (B)(6) = < 4 NG/L. REFERENCE RANGE: FEMALE <13 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060010 ALINITY I STAT HIGH SENSITIVITY TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 58191UD00 00380740194079

    Patients

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