BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY

    MDR report key: 10091801 · Received May 27, 2020

    Report

    Report Number
    3008344661-2020-00041
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    April 25, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR POTENTIAL FALSE REACTIVE AND CONFIRMED POSITIVE HBSAG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF COMPLAINT TEXT, INSTRUMENT RESULT LOGS, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. IN-HOUSE TESTING AND RETURN TESTING OF REAGENT LOT 04338FN00 WAS NOT COMPLETED AS THE REAGENT KIT HAS EXPIRED. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCTS. DEVICE HISTORY RECORD REVIEW ON LOTS 07389FN00 AND 04338FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS RELATED TO THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY, LOT NUMBER 07389FN00 AND ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY, LOT NUMBER 04338FN00 WAS IDENTIFIED. SEE MR# 3008344661-2020-00040 FOR ARCHITECT HBSAG QUALITATIVE II ASSAY, LOT NUMBER 07389FN00 SUBMISSION.

    Additional Manufacturer Narrative · 0

    SECTION D2. COMMON DEVICE NAME PROCODE EDITED TO LOM.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ARCHITECT (B)(6) RESULT ON A NEWBORN PATIENT. RESULTS PROVIDED: (B)(6) 2020 SID (B)(6) = 5.14 S/CO, (B)(6) 2020 SID (B)(6) = 2.47 / 2.23 S/CO. SAMPLE WAS SENT FOR CONFIRMATORY TESTING AND WAS POSITIVE. THE MOTHER WAS TESTED AND WAS NEGATIVE ON (B)(6) 2020 SID (B)(6) = 0.14 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555624 ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY HBSAG CONFIRMATORY LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 04338FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA ARC I1000SR MOD, 01L86-01, (B)(6)| ARCHITECT I1000SR ANALYZER LIST 01L86-01| ARCHITECT I1000SR ANALYZER LIST 01L86-01| LIST 02G22-25 LOT 07389FN00| LIST 02G22-25 LOT 07389FN00| SERIAL (B)(6) ARCH HBSAG QUALITATIVE II| SERIAL (B)(6) ARCH HBSAG QUALITATIVE II