BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 20705507 · Received November 18, 2024

    Report

    Report Number
    3008344661-2024-00137
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 22, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740138172
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P88.

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS WAS PERFORMED FOR THE LIKELY CAUSE REAGENT LOT NUMBER 65161FZ00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THIS LOT NUMBER AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLDWIDE DATA WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR THE LOT IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND WITHIN ESTABLISHED BASELINES, CONFIRMING THAT THIS LOT IS MEETING THE ALINITY I ANTI-HBS PRODUCT REQUIREMENTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A REVIEW OF THE PRODUCT LABELING INCLUDING SAMPLE INTEGRITY / HANDLING INSTRUCTIONS CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I ANTI-HBS KIT (LOT# 65161FZ00).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT ALINITY I ANTI-HBS RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = 16.24 / 7.236 / 6.95 MIU/ML. (B)(6) 2024 SID (B)(6) = 12 / 4.02 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 4.33 MIU/ML. (B)(6) 2024 SID (B)(6) = 16 / 4.42 MIU/ML. (B)(6) 2024 SID (B)(6) = 12 / 4.61 MIU/ML. (B)(6) 2024 SID (B)(6) = 12 / 6.80 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 7.13 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 7.26 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 7.86 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 8.01 MIU/ML. (B)(6) 2024 SID (B)(6) = 10 / 8.20 MIU/ML. (B)(6) 2024 SID (B)(6) =12 / 8.24 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 8.28 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 8.29 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 8.60 MIU/ML. (B)(6) 2024 SID (B)(6) = 12 / 8.83 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 8.90 MIU/ML. (B)(6) 2024 SID (B)(6) = 10 / 8.95 MIU/ML. (B)(6) 2024 SID (B)(6) = 13 / 8.99 MIU/ML. (B)(6) 2024 SID (B)(6) = 10 / 9.01 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 9.29 MIU/ML. (B)(6) 2024 SID (B)(6) = 11 / 9.29 MIU/ML. (B)(6) 2024 SID (B)(6) = 10 / 9.49 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT ALINITY I ANTI-HBS RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6)2024, SID (B)(6) = 16.24 / 7.236 / 6.95 MIU/ML. ON (B)(6)2024, SID (B)(6) = 12 / 4.02 MIU/ML. ON (B)(6)2024, SID (B)(6) = 11 / 4.33 MIU/ML. ON (B)(6)2024, SID (B)(6) = 16 / 4.42 MIU/ML. ON (B)(6)2024, SID (B)(6) = 12 / 4.61 MIU/ML. ON (B)(6) 2024, SID (B)(6) = 12 / 6.80 MIU/ML. ON (B)(6) 2024, SID (B)(6) = 11 / 7.13 MIU/ML. ON (B)(6) 2024, SID (B)(6) = 11 / 7.26 MIU/ML. ON (B)(6) 2024, SID (B)(6) = 11 / 7.86 MIU/ML. ON (B)(6)2024, SID (B)(6) = 11 / 8.01 MIU/ML ON (B)(6) 2024 ,SID (B)(6) = 10 / 8.20 MIU/ML ON (B)(6)2024 ,SID (B)(6) =12 / 8.24 MIU/ML ON (B)(6) 2024, SID (B)(6) = 11 / 8.28 MIU/ML ON (B)(6) 2024, SID (B)(6) = 11 / 8.29 MIU/ML ON (B)(6)2024, SID (B)(6) = 11 / 8.60 MIU/ML ON (B)(6) 2024 ,SID (B)(6) = 12 / 8.83 MIU/ML ON (B)(6)2024, SID (B)(6) = 11 / 8.90 MIU/ML ON (B)(6) 2024, SID (B)(6) = 10 / 8.95 MIU/ML ON (B)(6) 2024, SID (B)(6) = 13 / 8.99 MIU/ML ON (B)(6) 2024, SID (B)(6) = 10 / 9.01 MIU/ML ON (B)(6) 2024 ,SID (B)(6) = 11 / 9.29 MIU/ML ON (B)(6) 2024 ,SID (B)(6) = 11 / 9.29 MIU/ML ON (B)(6) 2024 SID (B)(6) = 10 / 9.49 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608538 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 65161FZ00 00380740138172

    Patients

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