BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 10024957 · Received May 5, 2020

    Report

    Report Number
    3008344661-2020-00034
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 21, 2020
    Report Date
    June 22, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO D2 PRODUCT CODE FROM INCORRECT KSJ TO THE CORRECT LOM. A SEARCH OF COMPLAINTS FOR LOT 06418FN00 IDENTIFIED NO SIMILAR COMPLAINTS AND NO TRENDS FOR THE CUSTOMER'S ISSUE. THE COMPLAINT INVESTIGATION FOR POTENTIAL FALSE NEGATIVE 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 SENSITIVITY TESTING OF PANELS WHICH MIMIC PATIENT SAMPLES WAS COMPLETED USING A RETAINED KIT OF LOT 06418FN00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. THE PATIENT MEDIAN RESULT FOR LIKELY CAUSE LOT NUMBER OF REAGENT WITHIN THE ESTABLISHED BASELINE, INDICATING THE LOT IS PERFORMING ACCEPTABLY. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH FALSE NONREACTIVE RESULTS. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG ASSAY, LOT NUMBER 06418FN00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION B5 WITH ADDITIONAL INFORMATION PROVIDED BY CUSTOMER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON 29MAY2020 : THE NEUTRALIZATION TESTING PERFORMED LATER, AND RESULTS WERE: SID (B)(6) HBSAG C1=0.19, HBSAG C2=6.32, %NEURALIZATION RATE RESULT=100.322 CONFIRMED HBSAG= POSITIVE, SID (B)(6) HBSAG C1=0.25, HBSAG C2=0.21, %NEUTRALIZATION RATE RESULT=NOT APPLICABLE, CONFIRMED HBSAG=NEGATIVE. THE CUSTOMER AGREES THAT SID (B)(6) IS TRUE POSITIVE HBSAG. SID (B)(6) HBSAG RESULT= NONREACTIVE, WHICH IS INCORRECT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Additional Manufacturer Narrative · 1

    COMPLETE INFORMATION FOR PATIENT INFORMATION, PATIENT IDENTIFIER = SID= (B)(6) AND SID (B)(6). 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 OBSERVED (B)(6) ARCHITECT HBSAG RESULTS ON ONE (B)(6) YEAR OLD MALE PATIENT DIAGNOSED WITH CHRONIC KIDNEY DISEASE. THE RESULTS WERE PROVIDED: ON (B)(6) 2020 SID (B)(6) INITIAL HBSAG RESULT=(B)(6), ANTI-HBS=(B)(6)), HBEAG= (B)(6), ANTI-HBE= (B)(6), ANTI-HBC= (B)(6); REDRAW SAME PATIENT ON (B)(6) 2020 SID (B)(6) ANTI-HBSAG= (B)(6), ANTI-HBS RESULT= (B)(6). ON (B)(6) 2020 THE CUSTOMER RETESTED SID (B)(6) ANTI-HBSAG RESULT= (B)(6), ANTI- HBS= (B)(6), HBEAG RESULT= (B)(6), ANTI-HBE RESULT= (B)(6), ANTI-HBC RESULT= (B)(6) / SID (B)(6) ANTI-HBSAG RESULT= (B)(6), ANTI-HBS RESULT= (B)(6), HBEAG= (B)(6), ANI-HBE RESULT=(B)(6), ANTI-HBC RESULT= (B)(6).THE NEUTRALIZATION TESTING PERFORMED LATER ON AND RESULTS WERE: SID (B)(6) HBSAG C1= (B)(6), HBSAG C2= (B)(6), %NEURALIZATION RATE RESULT=(B)(6) CONFIRMED HBSAG= (B)(6), SID (B)(6) HBSAG C1=(B)(6), HBSAG C2=(B)(6), %NEUTRALIZATION RATE RESULT=NOT APPLICABLE, CONFIRMED HBSAG=(B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490120 ARCHITECT HBSAG HBSAG LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 06418FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER| LN 03M74-02 (B)(6) | LN 03M74-02: SERIAL # (B)(6) | LN 03M74-02: SERIAL # (B)(6)