BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 10537587 · Received September 15, 2020

    Report

    Report Number
    3008344661-2020-00069
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    September 6, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. PERFORMANCE OF REAGENT LOT 11147FN00 WAS EVALUATED USING WORLD WIDE DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 11147FN00 FOR REACTIVE SAMPLES IS WITHIN THE ESTABLISHED CONTROL LIMITS, THEREFORE, THE PERFORMANCE OF THE LOT IS ACCEPTABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW ON LOT 11147FN00 DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG ASSAY, LOT NUMBER 11147FN00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED TO CORRECT SECTION D2B PROCODE: FROM KSJ TO LOM.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: SID (B)(6). ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (B)(6) ARCHITECT HBSAG RESULTS ON ONE PATIENT WHO TESTED (B)(6) IN (B)(6) 2020 AND IS CURRENTLY UNDERGOING TREATMENT. THE RESULTS PROVIDED WERE: SID: (B)(6), (B)(6)2020: INITIAL RESULT = NONREACTIVE (0.00 IU/ML), RETEST RESULT = NONREACTIVE (0.00 IU/ML) (LESS THAN 0.05 IU/ML = NONREACTIVE), PREVIOUS RESULT FROM (B)(6) 2020 WAS (B)(6) CONFIRMATION TEST. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003353 ARCHITECT HBSAG HBSAG LOM ABBOTT IRELAND 11147FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(6).| ARC I2K PROC MOD, 03M74-01, (B)(6)| ARC I2K PROC MOD, 03M74-01, (B)(6)| ARCHITECT I2000SR ANALYZER, LIST 03M74-01,