BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT HBSAG REAGENT KIT

    MDR report key: 16478249 · Received March 3, 2023

    Report

    Report Number
    3008344661-2023-00046
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 29, 2023
    Report Date
    March 31, 2023
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ARCHITECT HBSAG RESULTS 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 IN-HOUSE SENSITIVITY TESTING. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 42455FN00 AND THE COMPLAINT ISSUE. IN-HOUSE SENSITIVITY TESTING USING A RETAINED REAGENT KIT OF LOT 42455FN00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. PER PRODUCT LABELING, ALL INITIALLY REACTIVE SPECIMENS SHOULD BE RETESTED IN DUPLICATE. IF BOTH RETEST VALUES ARE NONREACTIVE, THE SPECIMEN MUST BE CONSIDERED NONREACTIVE FOR HBSAG. IF EITHER OF THE RETEST VALUES IS REACTIVE, THE SPECIMEN MUST BE CONSIDERED REPEATEDLY REACTIVE FOR HBSAG BY THE CRITERIA OF THE ARCHITECT HBSAG. REPEATEDLY REACTIVE SAMPLES SHOULD BE TESTED BY A NEUTRALIZING CONFIRMATORY TEST. SAMPLES WHICH ARE CONFIRMED BY NEUTRALIZATION WITH HUMAN ANTI-HBS MUST BE CONSIDERED POSITIVE FOR HBSAG. THE CUSTOMER DID NOT FOLLOW THE TESTING ALGORITHM OUTLINED IN THE PACKAGE INSERT. THEREFORE, THIS EVENT IS DEEMED ABNORMAL USE. A MALFUNCTION WAS NOT IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE HBSAG RESULT ON THE ARCHITECT I2000 FOR ONE PREGNANT FEMALE. THE ROCHE HBSAB GAVE BOTH POSITIVE AND NEGATIVE RESULTS. THE PATIENT UNDERWENT PROPHYLACTIC TREATMENT DUE TO HBSAG RESULT. THE FOLLOWING DATA WAS PROVIDED(SPECIMENS WITH CONCENTRATION VALUES < 0.05 IU/ML ARE CONSIDERED NONREACTIVE BY THE CRITERIA OF ARCHITECT HBSAG. SPECIMENS WITH CONCENTRATION VALUES = 0.05 IU/ML ARE CONSIDERED REACTIVE BY THE CRITERIA OF ARCHITECT HBSAG): (B)(6) 2022 HBSAG RESULT = 0.03; (B)(6) 2023 HBSAG RESULT = 0.21 ABBOTT HBSAB RESULT = 283.66; (B)(6) 2023 DNA RESULT = LOWER THAN THE LIMIT OF DETECTION; (B)(6) 2023 HBSAG RESULT = 0.2 ABBOTT HBSAB RESULT = 307.55; (B)(6) 2023 HBSAG RESULT = 0.22 ABBOTT HBSAB RESULT = 228.42; (B)(6) 2023 ROCHE HBSAG RESULT = NEGATIVE AFTER DELIVERY AND PATIENT WAS DISCHARGED. THE PATIENT UNDERWENT UNNECESSARY PROPHYLACTIC TREATMENT. PATIENT WAS DISCHARGED AFTER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772998 ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND 42455FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other ARC I2000SR INST, 03M74-02, ISR54141| ARC I2000SR INST, 03M74-02, ISR54141