BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 22141647 · Received June 4, 2025

    Report

    Report Number
    3002809144-2025-00176
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 25, 2025
    Report Date
    July 31, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162580
    PMA / PMN Number
    N/A
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84, WITH 510K/PMA/BLA NUMBER P080023.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION 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 TESTING OF THE COMPLAINT LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HBC ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 67557BE01. IN-HOUSE TESTING OF RETAINED REAGENT KIT OF THE ALINITY I ANTI-HBC COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, CLINICAL SENSITIVITY TESTING WAS PERFORMED ON THE COMPLAINT LOT USING PANELS WHICH MIMIC PATIENT SAMPLES. THE COMPLAINT LOT DETECTED THE SAME BLEEDS OF A SEROCONVERSION PANEL AS REACTIVE, THUS INDICATING THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT NEGATIVELY IMPACTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I ANTI-HBC REAGENT LOT 67557BE01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HBC RESULT FOR AN 80-YEAR-OLD MALE PATIENT IN THE UROLOGICAL SURGERY DEPARTMENT DIAGNOSED WITH BLADDER STONES. THE FOLLOWING DATA WAS PROVIDED: INITIAL ANTI-HBC RESULT = 0.47 S/CO (NONREACTIVE); REPEAT ANTI-HBC RESULT = 3.10 S/CO (REACTIVE). THE CUSTOMER REVIEWED HEPATITIS B FIVE-ASSAY PANEL AND DISCOVERED THAT THE POSITIVE ANTI-HBS AND ANTI-HBE CONSTITUTED A RARE PATTERN, AND THE CUSTOMER WAS SKEPTICAL OF THE INITIAL ANTI-HBC RESULT. THE REACTIVE RESULT OF 3.10 S/CO WAS REPORTED OUT TO THE CLINICAL PHYSICIAN. OTHER HEPATITIS B FIVE ASSAY PANEL TESTING PERFORMED: HBSAG 0.00 IU/ML NONREACTIVE, ANTI-HBS 52.86 MIU/ML REACTIVE, HBEAG 0.34 S/CO NONREACTIVE, ANTI-HBE 0.65 S/CO REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HBC RESULT FOR AN 80-YEAR-OLD MALE PATIENT IN THE UROLOGICAL SURGERY DEPARTMENT DIAGNOSED WITH BLADDER STONES. THE FOLLOWING DATA WAS PROVIDED: INITIAL ANTI-HBC RESULT = 0.47 S/CO (NONREACTIVE); REPEAT ANTI-HBC RESULT = 3.10 S/CO (REACTIVE). THE CUSTOMER REVIEWED HEPATITIS B FIVE-ASSAY PANEL AND DISCOVERED THAT THE POSITIVE ANTI-HBS AND ANTI-HBE CONSTITUTED A RARE PATTERN, AND THE CUSTOMER WAS SKEPTICAL OF THE INITIAL ANTI-HBC RESULT. THE REACTIVE RESULT OF 3.10 S/CO WAS REPORTED OUT TO THE CLINICAL PHYSICIAN. OTHER HEPATITIS B FIVE ASSAY PANEL TESTING PERFORMED: HBSAG 0.00 IU/ML NONREACTIVE, ANTI-HBS 52.86 MIU/ML REACTIVE, HBEAG 0.34 S/CO NONREACTIVE, ANTI-HBE 0.65 S/CO REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626152 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 67557BE01 00380740162580

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)