BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    MDR report key: 19940445 · Received August 8, 2024

    Report

    Report Number
    3008344661-2024-00091
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130404
    PMA / PMN Number
    P110029
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P10-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P10-31.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I HBSAG REAGENT LOT 59361FZ00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. HISTORICAL PERFORMANCE IN THE FIELD USING WORLDWIDE DATA WAS REVIEWED AND DETERMINED THAT THE PATIENT MEDIAN RESULT FOR THE LOT IS COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE PRODUCT LOT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I HBSAG QUALITATIVE II REAGENT (LOT# 59361FZ00).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II AND HBSAG CONFIRMATORY RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = HBSAG = 232 / 235 S/CO, CONFIRMED POSITIVE WITH 100% NEUTRALIZATION ON ANOTHER ALINITY REPEAT FROM ALIQUOT TUBE FROM SAME SAMPLE ON (B)(6) 2024: HBSAG = 0.3 S/CO, NOT CONFIRMED BY NEUTRALIZATION. PATIENT HAS A HISTORY OF NEGATIVE HBSAG. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II AND HBSAG CONFIRMATORY RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = HBSAG = 232 / 235 S/CO, CONFIRMED POSITIVE WITH 100% NEUTRALIZATION ON ANOTHER ALINITY. REPEAT FROM ALIQUOT TUBE FROM SAME SAMPLE ON (B)(6) 2024: HBSAG = 0.3 S/CO, NOT CONFIRMED BY NEUTRALIZATION. PATIENT HAS A HISTORY OF NEGATIVE HBSAG. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532047 ALINITY I HBSAG QUALITATIVE II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 59361FZ00 00380740130404

    Patients

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