BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

    MDR report key: 19644477 · Received July 1, 2024

    Report

    Report Number
    3008344661-2024-00078
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740002466
    PMA / PMN Number
    P110029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2G23 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P54. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY LOT 54200FN00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. INHOUSE TESTING DETERMINED THAT THE CLINICAL SPECIFICITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY (LOT# 54200FN00).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) (SN#(B)(6) INITIAL = 2.81 S/CO, REPEATED AFTER CENTRIFUGATION = 2.79 / 2.78 S/ CO ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY TEST RUN: SID (B)(6) ON SN# (B)(6) C2 RESULT = 1.91 S/CO REACTIVE DIASORIN = NON-REACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) (SN# (B)(6)) INITIAL = 2.81 S/CO, REPEATED AFTER CENTRIFUGATION = 2.79 / 2.78 S/ CO; ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY TEST RUN: SID (B)(6) ON SN# (B)(6) C2 RESULT = 1.91 S/CO REACTIVE; DIASORIN = NON-REACTIVE; NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974116 ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 54200FN00 00380740002466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6).| ARC I2000SR INST, 03M74-02, (B)(6).