BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG REAGENT KIT

    MDR report key: 10857501 · Received November 17, 2020

    Report

    Report Number
    3008344661-2020-00118
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Report Date
    January 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

    IT WAS DISCOVERED ON (B)(6) 2020 THAT THE D2 PROCODE FOR THE SUSPECT MEDICAL DEVICE IN THE INITIAL EMDR WAS INCORRECT. THIS FOLLOW-UP EMDR IS BEING SUBMITTED TO CORRECT THE PROCODE FROM LOL TO LOM.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSELY NONREACTIVE RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND FIELD DATA REVIEW. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. HISTORICAL PERFORMANCE OF THE LIKELY CAUSE LOT WAS EVALUATED USING WORLD WIDE DATA FROM ABBOTTLINK. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE LIKELY CAUSE LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG, LOT 07510FN00 WAS IDENTIFIED. IN THIS CASE, THE REAGENT WAS EXPIRED WHEN THE SAMPLE WAS TESTED. PER PRODUCT LABELING, DO NOT USE REAGENT KITS BEYOND THE EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE FOLLOWING ARCHITECT HEPATITIS B RESULTS WERE GENERATED FOR A (B)(6) YEAR OLD FEMALE (B)(6) PATIENT SID (B)(6). (B)(6). THE PATIENT WAS TESTED AT ANOTHER INSTITUTION USING AN ELISA METHOD AND RESULTS WERE (B)(6). THE CUSTOMER RETESTED THE SAMPLE AND THE ARCHITECT RETEST RESULTS WERE CONSISTENT WITH THE INITIAL TEST RESULTS. THE CUSTOMER TESTED THE SAMPLE FOR (B)(6) USING AN ELISA METHOD AND THE RESULT WAS (B)(6). THE CUSTOMER BELIEVES THAT THE ARCHITECT HBSAG QUANTITATIVE II RESULT IS (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321404 ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND 07510FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ARC I2000SR INST, 03M74-02, (B)(4)| ARC I2000SR INST, 03M74-02, (B)(4)| ARC I2000SR INST, 03M74-02,(B)(4)