BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG REAGENT KIT

    MDR report key: 10944018 · Received December 4, 2020

    Report

    Report Number
    3008344661-2020-00128
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 21, 2020
    Report Date
    February 18, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSE NON-REACTIVE ARCHITECT HBSAG RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRENDING REPORTS FOR THE ARCHITECT HBSAG REAGENT DID NOT IDENTIFY ANY RELATED TRENDS. SENSITIVITY TESTING WAS PERFORMED USING PANELS, WHICH MIMICS PATIENT SAMPLES, AND AN IN-HOUSE RETAINED KIT OF LOT NUMBER 12069FN00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF ARCHITECT HBSAG, LOT NUMBER 12069FN00, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, SECTION D2B: PROCODE UPDATED FROM LOL TO LOM.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 06C36-78, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 04P53.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT HBSAG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<0.05 IU/ML IS NONREACTIVE, >/=0.05 IU/ML IS REACTIVE): SAMPLE ID: (B)(6); INITIAL RESULT, ON (B)(6) 2020, WAS <0.05, REPEAT, ON (B)(6) 2020, WAS 0.05, SAMPLE WAS RECENTRIFUGED AND REPEAT WAS 0.07 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409911 ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND 12069FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I2000SR INST, 03M74-02, ISR61242| ARC I2000SR INST, 03M74-02, ISR61242| ARC I2000SR INST, 03M74-02, ISR61242| ARC I2000SR INST, 03M74-02, ISR61242