BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HAVAB-IGG REAGENT KIT

    MDR report key: 22326608 · Received June 25, 2025

    Report

    Report Number
    3002809144-2025-00204
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 30, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740131333
    PMA / PMN Number
    K113704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: PATIENT 1 - SIDS (B)(6), PATIENT 2 SIDS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P26 (ALINITY I HAVAB IGG) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6S93 (HAVAB IGG II) WITH 510K/PMA/BLA NUMBER K222850 AND LIST NUMBER 8P27 (ALINITY I HAVAB IGG) WITH 510K/PMA/BLA NUMBER K113704. 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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY REACTIVE ALINITY I HAVAB IGG 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 FIELD DATA REVIEW. 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 HAVAB IGG 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 68682BE00. THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I HAVAB IGG REAGENTS IN THE FIELD WAS REVIEWED FROM CUSTOMERS USING WORLDWIDE DATA. THE MEDIAN VALUE AND THE NUMBER OF STANDARD DEVIATIONS TO CUTOFF OF THE NEGATIVE POPULATION FOR THE LOT 68682BE00 IS WITHIN THE ESTABLISHED LIMITS. THEREFORE, THE OVERALL PERFORMANCE REGARDING SPECIFICITY IS ACCEPTABLE AND COMPARABLE TO HISTORICAL REAGENT LOT PERFORMANCE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HAVAB IGG ASSAY FOR LOT NUMBER 68682BE00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY REACTIVE ALINITY I HAVAB IGG RESULTS FOR TWO 8-YEAR-OLD MALE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: THE CUSTOMER REPORTED BOTH PATIENTS ON (B)(6) 2025 WERE NON-REACTIVE FOR HAVAB IGG AND HAVAB IGM. (B)(6) 2025 SAMPLE 1 (PATIENT 1) SID (B)(6) INITIAL RESULT LOT (68682BE00) = 1.34 S/CO REACTIVE, REPEAT RESULT WITH SID (B)(6) ON (B)(6) 2025 WITH NEW LOT (72396BE00) = 0.07 S/CO NON-REACTIVE (B)(6) 2025 SAMPLE 2 (PATIENT 2) SID (B)(6) INITIAL RESULT (LOT 68682BE00) = 1.43 REACTIVE, RETEST RESULT (B)(6) 2025 WITH SID (B)(6) (LOT 68682BE00) = REACTIVE 1.47, REPEAT RESULT WITH NEW LOT (72396BE00) WITH SID (B)(6) RESULT = 1.43 S/CO, LIAISON XL RESULT = NEGATIVE THE CUSTOMER MENTIONED BOTH PATIENTS WERE IN CONTACT WITH HAV POSITIVE BEFORE (B)(6) 2025. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY REACTIVE ALINITY I HAVAB IGG RESULTS FOR TWO 8-YEAR-OLD MALE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: THE CUSTOMER REPORTED BOTH PATIENTS ON (B)(6) 2025 WERE NON-REACTIVE FOR HAVAB IGG AND HAVAB IGM. (B)(6) 2025 SAMPLE 1 (PATIENT 1) SID (B)(6) INITIAL RESULT LOT (68682BE00) = 1.34 S/CO REACTIVE, REPEAT RESULT WITH SID (B)(6) ON (B)(6) 2025 WITH NEW LOT (72396BE00) = 0.07 S/CO NON-REACTIVE. (B)(6) 2025 SAMPLE 2 (PATIENT 2) SID (B)(6) INITIAL RESULT (LOT 68682BE00) = 1.43 REACTIVE, RETEST RESULT (B)(6) 2025 WITH SID (B)(6) (LOT 68682BE00) = REACTIVE 1.47, REPEAT RESULT WITH NEW LOT (72396BE00) WITH SID (B)(6) RESULT = 1.43 S/CO, LIAISON XL RESULT = NEGATIVE. THE CUSTOMER MENTIONED BOTH PATIENTS WERE IN CONTACT WITH HAV POSITIVE BEFORE (B)(6) 2025. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360864 ALINITY I HAVAB-IGG REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) LOL ABBOTT GMBH 68682BE00 00380740131333

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male