BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 10548878 · Received September 17, 2020

    Report

    Report Number
    3008344661-2020-00070
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 26, 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

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

    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 · 1

    PATIENT IDENTIFIER SID (B)(6). ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. 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 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT (B)(6) RESULTS ON A (B)(6) YEAR-OLD MALE PATIENT WITH SUSPECTED REACTIVATION OF (B)(6). THE PATIENT STARTED ANTIVIRAL TREATMENT WITH (B)(6) NUCLEIC ACID ON (B)(6) 2020. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2020 SID (B)(6) GENERATED THE FOLLOWING RESULTS ON THE ARCHITECT I2000SR ANALYZER: (B)(6) 0.00 IU/ML (NEGATIVE), (B)(6) 117.24 MIU/ML, (B)(6)8.07 / 8.36 S/CO (REACTIVE); (B)(6) 0.09 S/CO (NONREACTIVE); (B)(6) AG/AB 0.09 S/CO (NONREACTIVE); ON (B)(6) 2020 THE FOLLOWING RESULTS WERE GENERATED USING AN ALTERNATE METHOD: (B)(6) DNA QUANTITATIVE TEST 4 LOG IU/ML, (B)(6) NEGATIVE, (B)(6) POSITIVE, (B)(6) IGM POSITIVE (5 S/CO); ON (B)(6) 2020 (B)(6) DNA QUANTITATIVE 3.1 LOG IU/ML, (B)(6) NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014082 ARCHITECT HBSAG HBSAG LOM ABBOTT IRELAND 11147FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR ARC I2K PROC MOD, 03M74-01, (B)(4)| ARC I2K PROC MOD, 03M74-01, (B)(4)| ARCHITECT I2000SR ANALYZER, LIST 03M74-01,| SERIAL (B)(4)