BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG REAGENT KIT

    MDR report key: 12638513 · Received October 15, 2021

    Report

    Report Number
    3008344661-2021-00185
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    July 14, 2021
    Report Date
    February 2, 2022
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADVERSE EVENT PROBLEM: MEDICAL DEVICE PROBLEM CODE: INITIALLY: A090803; CHANGED TO: A090810.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53. THE COMPLAINT INVESTIGATION FOR A (B)(6) ARCHITECT HBSAG RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE PRODUCT FOR THE ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE LIST NUMBER ASSOCIATED WITH THE COMPLAINT. THE FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT HBSAG ASSAY USING WORLDWIDE DATABASE. THE LIKELY CAUSE LOT IS UNKNOWN IN THIS CASE, HOWEVER REVIEW OF THE WITHIN DATE LOTS SHOW THAT THE PATIENT MEDIAN RESULT FALLS WITHIN 2SD OF THE ESTABLISHED LIMITS INDICATING THAT THE LOTS ARE COMPARABLE AND PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. THROUGH TROUBLESHOOTING, CUSTOMER SUPPORT PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAS A HISTORY OF TRANSIENT (B)(6) AND IS THEREFORE (B)(6) AND HBC ANTIBODY-(B)(6). THE (B)(6) VIRUS HAD LIKELY REMAINED INACTIVE FOR A LONG TIME, SO THAT THERE WAS NO (B)(6) IN THE BLOOD AND THE SAMPLE TESTED (B)(6). IN THIS INSTANCE, THE PATIENT'S LIVER FUNCTION DETERIORATED DUE TO MULTIPLE BLOOD TRANSFUSIONS AND ALCOHOLIC (B)(6). THE HIGH AMMONIA LEVEL STRONGLY SUGGESTS CIRRHOSIS, AND THE PCR TEST WAS (B)(6) FOR (B)(6)-DNA BECAUSE (B)(6) ITSELF, WHICH HAD BEEN DORMANT IN THE HEPATOCYTES, WAS RELEASED INTO THE BLOODSTREAM. HOWEVER, (B)(6) WAS NOT REACTIVATED, SO THAT THERE WAS NO REACTIVATION OR MULTIPLICATION OF THE VIRUS, THUS LIKELY RESULTING IN (B)(6). THE OVERALL SENSITIVITY FOR THE ARCHITECT HBSAG ASSAY WAS ESTIMATED TO BE 99.52% (418/420) WITH A 95% CONFIDENCE INTERVAL OF 98.29% TO 99.94%. IN ADDITION, PER PRODUCT LABELING, IF THE (B)(6) RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD BE USED IN CONJUNCTION WITH PATIENT HISTORY AND OTHER (B)(6) MARKERS FOR DIAGNOSIS OF ACUTE OR CHRONIC INFECTION. IN THIS CASE ADDITIONAL (B)(6) MARKERS WERE TESTED. THERE IS THE POSSIBILITY OF OCCULT INFECTION WITH THESE CASES GIVEN THE (B)(6) DNA RESULTS. SAMPLES WHICH ARE (B)(6) DNA (B)(6) BUT WHERE (B)(6) SURFACE ANTIGEN ((B)(6)) IS UNDETECTABLE: A GROUP OF PATIENTS WITH CHRONIC (B)(6) INFECTION HAS BEEN IDENTIFIED BY SENSITIVE, MOLECULAR TESTING FOR (B)(6) DNA. MEMBERS OF THIS GROUP ARE OFTEN REFERRED TO AS HAVING OCCULT (B)(6) INFECTION WHICH IS DIAGNOSED WHEN AN (B)(6) DNA TEST IS (B)(6), BUT (B)(6) SURFACE ANTIGEN ((B)(6)) IS UNDETECTABLE. OCCULT (B)(6) INFECTION (OBI) OCCURS IN A NUMBER OF CLINICAL SETTINGS AND MAY REPRESENT: ACUTE INFECTION IN THE WINDOW PERIOD, (B)(6) TAIL END OF CHRONIC (B)(6) INFECTION, PERSISTENCE OF REPLICATION AT LOW LEVEL AFTER RECOVERY IN THE PRESENCE OF ANTI-HBS, OR (IV) OCCURRENCE OF AN ESCAPE MUTANT IN VACCINATED OR UNVACCINATED INDIVIDUALS NOT DETECTED BY CURRENT (B)(6) ASSAYS.H. W. REESINK ET AL. OCCULT HEPATITIS B INFECTION IN BLOOD DONORS. VOX SANGUINIS (2008) 94 , 153¿166. MICHAEL TORBENSON AND DAVID L THOMAS. OCCULT HEPATITIS B. LANCET INFECT DIS 2002; 2: 479¿86. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY FOR ARCHITECT HBSAG WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A (B)(6) ARCHITECT HBSAG RESULT FOR A (B)(6) MALE WITH A HISTORY OF TRANSIENT (B)(6), ALCOHOLIC LIVER CIRRHOSIS, AND ANEMIA. THE PATIENT HAS HAD MULTIPLE BLOOD TRANSFUSIONS DUE TO ANEMIA, BUT THE CAUSE OF THE ANEMIA IS UNKNOWN. THE PATIENT WAS HOSPITALIZED REPEATEDLY DUE TO ALCOHOLIC LIVER CIRRHOSIS AND HAD AN ELEVATED AMMONIA LEVEL OF 135 UG/DL (12-66 UG/DL). ON (B)(6) 2021, ARCHITECT HBSAG RESULT: (B)(6)); ARCHITECT ANTI-HBS: (B)(6); REAL-TIME PCR METHOD (HBV-DNA QUANTITATIVE) RESULT:(B)(6)); THE PATIENT HAD A (B)(6) ANTI - HBC RESULT OF (B)(6) PRIOR TO THE BLOOD TRANSFUSION ON (B)(6) 2021. A REVIEW WAS PERFORMED FROM THE PAST SIX MONTHS AND DISCOVERED TWO ADDITIONAL PATIENTS WHO TESTED HBSAG (B)(6) AND HBV-DNA (B)(6). THE 2 PATIENTS DIDN¿T HAVE ANY MAJOR PROBLEMS WITH THEIR LIVER. NO OTHER SPECIFIC PATIENT INFORMATION WAS PROVIDED. THERE IS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537284 ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male ARC I2K PROC MOD, 03M74-01, ISR62196| ARC I2K PROC MOD, 03M74-01, ISR62196