BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 21000889 · Received December 23, 2024

    Report

    Report Number
    3008344661-2024-00156
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    January 1, 2018
    Report Date
    March 4, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    OBTAINED FURTHER INFORMATION ON 21FEB2025: UPDATED SECTION D4: SUSPECTED MEDICAL DEVICE CATALOG NUMBER: THE SIZE CODE CHANGED TO -22 FROM -52 FOR LIST NUMBER 8P08, ALINITY I HBSAG REAGENT. THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ALINITY I HBSAG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF THE COMPLAINT TEXT, TRENDING DATA, LABELLING AND DEVICE HISTORY RECORDS OF ALINITY I HBSAG ASSAY, LOT UNKNOWN. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HBSAG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR ALINITY I HBSAG ASSAY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I HBSAG ASSAY, LOT UNKNOWN.

    Description of Event or Problem · 0

    ABBOTT WAS INFORMED OF A FALSE NONREACTIVE ALINITY I HBSAG RESULTS GENERATED ON A DONOR SPECIMEN FROM 2018. THE INFORMANT (FRENCH KOL) STATED THE SPECIMEN GENERATED A NEGATIVE ABBOTT HBSAG RESULT IN 2018 BUT GENERATED A POSITIVE NAT RESULT IN 2018 ALSO. THE BLOOD UNIT WAS NEVER RELEASED FOR TRANSFUSION. THE FRENCH KOL FURTHER STATED THAT THE SPECIMEN HAS GENERATED POSITIVE RESULTS VIA ALTERNATIVE SEROLOGY EIA AND WITH OTHER LUMINESCENCE ASSAYS THIS YEAR, HOWEVER, DID NOT PROVIDE THE EXACT DATES THESE TESTS WERE PERFORMED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ABBOTT CONTINUES TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION, INCLUDING INQUIRING ABOUT WHICH HOSPITAL GENERATED THE 2018 NEGATIVE ABBOTT HBSAG RESULTS; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    ABBOTT WAS INFORMED OF A FALSE NONREACTIVE ALINITY I HBSAG RESULTS GENERATED ON A DONOR SPECIMEN FROM 2018. THE INFORMANT (FRENCH KOL) STATED THE SPECIMEN GENERATED A NEGATIVE ABBOTT HBSAG RESULT IN 2018 BUT GENERATED A POSITIVE NAT RESULT IN 2018 ALSO. THE BLOOD UNIT WAS NEVER RELEASED FOR TRANSFUSION. THE FRENCH KOL FURTHER STATED THAT THE SPECIMEN HAS GENERATED POSITIVE RESULTS VIA ALTERNATIVE SEROLOGY EIA AND WITH OTHER LUMINESCENCE ASSAYS THIS YEAR, HOWEVER, DID NOT PROVIDE THE EXACT DATES THESE TESTS WERE PERFORMED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ABBOTT CONTINUES TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION, INCLUDING INQUIRING ABOUT WHICH HOSPITAL GENERATED THE 2018 NEGATIVE ABBOTT HBSAG RESULTS; HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622035 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740130206

    Patients

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