BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

    MDR report key: 19940467 · Received August 8, 2024

    Report

    Report Number
    3008344661-2024-00092
    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
    00380740130466
    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

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I HBSAG QUALITATIVE II CONFIRMATORY LOT 59351FZ00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. ADDITIONALLY, CLINICAL SPECIFICITY OF THE ALINITY I HBSAG QUALITATIVE II CONFIRMATORY ASSAY HAS BEEN EVALUATED WITH A RETAINED IN-HOUSE KIT OF THE SAME LOT# 59351FZ00 AND MET ALL SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ALINITY I HBSAG PRODUCT REQUIREMENTS. 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 CONFIRMATORY (LOT# 59351FZ00).

    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 8P11-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P11-21.

    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
    1026246 ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 59351FZ00 00380740130466

    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)