BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HAVAB IGG REAGENT KIT

    MDR report key: 22565366 · Received July 22, 2025

    Report

    Report Number
    3002809144-2025-00243
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 8, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740131333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A FIELD DATA REVIEW, AND A LABELING REVIEW. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE. A 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. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 68682BE00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I HAVAB IGG REAGENTS WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO CUTOFF AND PATIENT MEDIAN VALUES OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I HAVAB IGG REAGENT, LOT NUMBER 68682BE00.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY REACTIVE ALINITY I HAVAB IGG RESULTS ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: RESULTS >/= 1.00 S/CO ARE REACTIVE): (B)(4). PROCESSED ON (B)(6) 2025 INITIAL RESULT = 1.32 REPEAT RESULT AFTER RECENTRIFUGATION = 0.51 S/CO REPEATED AGAIN ON (B)(6) 2025 RESULTS = 6.7 AND 0.45 S/CO OTHER LABORATORY RESULTS WERE NEGATIVE = 0.70,0.58, AND 0.69 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY REACTIVE ALINITY I HAVAB IGG RESULTS ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: RESULTS >/= 1.00 S/CO ARE REACTIVE): SID: (B)(6): PROCESSED ON (B)(6) 2025 INITIAL RESULT = 1.32 REPEAT RESULT AFTER RECENTRIFUGATION = 0.51 S/CO REPEATED AGAIN ON (B)(6) 2025 RESULTS = 6.7 AND 0.45 S/CO. OTHER LABORATORY RESULTS WERE NEGATIVE = 0.70, 0.58, AND 0.69 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293852 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 NA Unknown ALNTY I PROCESSING MODU, 03R65-01,(B)(6).| ALNTY I PROCESSING MODU, 03R65-01,(B)(6).