BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HAVAB IGG REAGENT KIT

    MDR report key: 22850129 · Received August 20, 2025

    Report

    Report Number
    3002809144-2025-00270
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740131333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P26 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P27, WITH 510K/PMA/BLA NUMBER K113704.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSE REACTIVE ALINITY I HAVAB IGG RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND LABELING REVIEW. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. 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 ASSAY WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE STANDARD DEVIATION TO CUTOFF FOR THE NEGATIVE POPULATION AND MEDIAN VALUES OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I HAVAB IGG REAGENT LOT 68682BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I HAVAB IGG RESULT ON A PATIENT WITH REAGENT LOT# 68682BE00. RESULTS PROVIDED: (B)(6) 2025 SID (B)(6) = 2.12 / 2.18 / 2.43 / 2.42 S/CO, ANOTHER LOT# = 0.28 /0.28 / 0.33 / 0.30 S/CO. SAME PATIENT (EDTA PLASMA SAMPLE) LOT# 68682BE00 = 1.94 / 2.56 / 2.074 S/CO, ANOTHER LOT# = 0.23 / 0.24 / 0.28 / 0.29 S/CO. PREVIOUS HAVAB IGG FROM (B)(6) 2023 SID (B)(6) = 2.91 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I HAVAB IGG RESULT ON A PATIENT WITH REAGENT LOT# 68682BE00. RESULTS PROVIDED: ON (B)(6) 2025, SID (B)(6) = 2.12 / 2.18 / 2.43 / 2.42 S/CO, ANOTHER LOT# = 0.28 /0.28 / 0.33 / 0.30 S/CO. SAME PATIENT (EDTA PLASMA SAMPLE) LOT# 68682BE00 = 1.94 / 2.56 / 2.074 S/CO, ANOTHER LOT# = 0.23 / 0.24 / 0.28 / 0.29 S/CO. PREVIOUS HAVAB IGG FROM (B)(6) 2023, SID (B)(6) = 2.91 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373921 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, AI05275