BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 20048279 · Received August 23, 2024

    Report

    Report Number
    3008344661-2024-00097
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    April 23, 2024
    Report Date
    September 5, 2024
    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

    H6 - MEDICAL DEVICE PROBLEM CODE: UPDATED FROM A090803 TO A090810. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. CLINICAL SENSITIVITY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT OF COMPLAINT LOT 57073FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND STATES 'ALINITY I HBSAG ASSAY (LIST NUMBER 8P08) SHOULD BE USED TO QUANTIFY ONLY THOSE SAMPLES PREVIOUSLY DETERMINED TO BE REACTIVE BY A NEUTRALIZING CONFIRMATORY TEST. THE TESTING ALGORITHM FOR THIS ASSAY IS COMPATIBLE WITH USE FOR MONITORING PURPOSES AND NOT FOR SCREENING'. IN THIS CASE THE CUSTOMER DID NOT PREVIOUSLY OBTAIN CONFIRMED POSITIVE RESULTS FOR THIS PATIENT. BASED ON THE INVESTIGATION, A MALFUNCTION WAS NOT IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE ALINITY I HBSAG QUANTITATIVE REAGENT, LOT 57073FN00, MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P08 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE ALINITY I HBSAG QUALITATIVE II RESULTS AND ALINITY I HBSAG QUANT. RESULTS FOR ONE PATIENT SAMPLE THAT HAS A MUTATION OF THE S GENE (G145R). THE CUSTOMER STATED THAT A SAMPLE TAKEN ON (B)(6) 2024 WAS TESTED AND GENERATED A NEGATIVE QUALITATIVE HBSAG AND A NEGATIVE QUANTITATIVE HBSAG RESULTS, HOWEVER THE SAMPLE GENERATED A WEAK POSITIVE WHEN TESTED WITH THE VIRAL LOAD. THE PATIENT WAS RE-SAMPLED ON (B)(6) 2024 AND STILL GENERATED NEGATIVE RESULTS FOR THE QUALITATIVE HBSAG AND QUANTITATIVE HBSAG AND A WEAKLY POSITIVE RESULT FOR THE VIRAL LOAD AGAIN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE ALINITY I HBSAG QUALITATIVE II RESULTS AND ALINITY I HBSAG QUANT. RESULTS FOR ONE PATIENT SAMPLE THAT HAS A MUTATION OF THE S GENE (G145R). THE CUSTOMER STATED THAT A SAMPLE TAKEN ON (B)(6) 2024 WAS TESTED AND GENERATED A NEGATIVE QUALITATIVE HBSAG AND A NEGATIVE QUANTITATIVE HBSAG RESULTS, HOWEVER THE SAMPLE GENERATED A WEAK POSITIVE WHEN TESTED WITH THE VIRAL LOAD. THE PATIENT WAS RE-SAMPLED ON (B)(6) 2024 AND STILL GENERATED NEGATIVE RESULTS FOR THE QUALITATIVE HBSAG AND QUANTITATIVE HBSAG AND A WEAKLY POSITIVE RESULT FOR THE VIRAL LOAD AGAIN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312340 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 57073FN00 00380740130206

    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)