BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 21000976 · Received December 23, 2024

    Report

    Report Number
    3008344661-2024-00157
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 4, 2024
    Report Date
    March 3, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740138172
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY FOR SECTION A1: PATIENT IDENTIFIER: (B)(6). 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 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 WITH A RETAINED PRODUCT LOT AND LABELING 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. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HBS 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 61065FZ00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE LOT NUMBER 61065FZ00 AND COMPLAINT ISSUE. IN-HOUSE SPECIFICITY TESTING WAS COMPLETED WITH RETAINED COMPLAINT LOT NUMBER 61065FZ00. ALL SPECIFICATIONS WERE MET INDICATING THAT LOT 61065FZ00 IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HBS REAGENT FOR LOT NUMBER 61065FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I ANTI-HBS FOR MULTIPLE PATIENTS. THE CUSTOMER ALSO REPORTED MULTIPLE ERROR CODE 3424, R1 ASPIRATION FAILURES WHEN THE DISCREPANT RESULTS WERE GENERATED. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE <10 MIU/ML): SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 42.90 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 8.13 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 25.02 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 1.82 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 17.41 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 1.17 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 50.32 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 9.46 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 17.01 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 0.86 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 16.48 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 1.20 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 20.58 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 0.88 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 24.68 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 1.89 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 55.50 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 9.63 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 34.39 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 5.46 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 18.14 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 2.42 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 16.61 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 1.02 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 33.33 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 2.65 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 12.07 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 1.19 MIU/ML. SID: (B)(6), ON (B)(6) 2024, INITIAL ANTI-HBS RESULT= 15.82 MIU/ML; ON (B)(6) 2024, REPEAT RESULT= 1.79 MIU/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 MULTIPLE PATIENTS. THE CUSTOMER ALSO REPORTED MULTIPLE ERROR CODE 3424, R1 ASPIRATION FAILURES WHEN THE DISCREPANT RESULTS WERE GENERATED. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE <10 MIU/ML): SID (B)(6) ,(B)(6) 2024, INITIAL ANTI-HBS RESULT= 42.90 MIU/ML; (B)(6) 2024, REPEAT RESULT= 8.13 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 25.02 MIU/ML; (B)(6) 2024, REPEAT RESULT= 1.82 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 17.41 MIU/ML; (B)(6) 2024, REPEAT RESULT= 1.17 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 50.32 MIU/ML; (B)(6) 2024, REPEAT RESULT= 9.46 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 17.01 MIU/ML; (B)(6) 2024, REPEAT RESULT= 0.86 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 16.48 MIU/ML; (B)(6) 2024, REPEAT RESULT= 1.20 MIU/ML SID (B)(6) ,(B)(6) 2024, INITIAL ANTI-HBS RESULT= 20.58 MIU/ML; (B)(6) 2024, REPEAT RESULT= 0.88 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 24.68 MIU/ML; (B)(6) 2024, REPEAT RESULT= 1.89 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 55.50 MIU/ML; (B)(6) 2024, REPEAT RESULT= 9.63 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 34.39 MIU/ML; (B)(6) 2024, REPEAT RESULT= 5.46 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 18.14 MIU/ML; (B)(6) 2024, REPEAT RESULT= 2.42 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 16.61 MIU/ML; (B)(6) 2024, REPEAT RESULT= 1.02 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 33.33 MIU/ML; (B)(6) 2024, REPEAT RESULT= 2.65 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 12.07 MIU/ML; (B)(6) 2024, REPEAT RESULT= 1.19 MIU/ML SID (B)(6) , (B)(6) 2024, INITIAL ANTI-HBS RESULT= 15.82 MIU/ML; (B)(6) 2024, REPEAT RESULT= 1.79 MIU/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616744 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 61065FZ00 00380740138172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, AI25878| ALNTY I PROCESSING MODU, 03R65-01, AI25878