BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 20773470 · Received November 25, 2024

    Report

    Report Number
    3008344661-2024-00140
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 7, 2024
    Report Date
    January 30, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED AND SUPPORTS THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 61065FZ01, HOWEVER, NO TRENDS WERE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT 61065FZ01 AND ISSUE. IN-HOUSE SPECIFICITY TESTING WAS COMPLETED WITH RETAINED COMPLAINT LOT NUMBER 61065FZ01. SPECIFICITY TESTING MET ACCEPTANCE CRITERIA INDICATING THE PRODUCT IS PERFORMING AS EXPECTED. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HBS REAGENT, LOT 61065FZ01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P88, WITH 510K/PMA/BLA NUMBER P050051. 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 FALSE REACTIVE ALINITY I ANTI-HBS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SAMPLE A, INITIAL ANTI-HBS RESULT= POSITIVE, REPEAT RESULT= 21.198 MIU/ML (REFERENCE RANGE <10.00 MIU/ML); ROCHE ANTI-HBS RESULT= 2.00 MIU/ML (REFERENCE RANGE <10.00MIU/ML) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I ANTI-HBS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SAMPLE A, INITIAL ANTI-HBS RESULT= POSITIVE, REPEAT RESULT= 21.198 MIU/ML (REFERENCE RANGE <10.00 MIU/ML); ROCHE ANTI-HBS RESULT= 2.00 MIU/ML (REFERENCE RANGE <10.00MIU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236494 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 61065FZ01 00380740159900

    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).