BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S HBSAG

    MDR report key: 8995120 · Received September 11, 2019

    Report

    Report Number
    3008344661-2019-00114
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    April 8, 2019
    Report Date
    September 16, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D. MEDICAL DEVICE INFORMATION 1. BRAND NAME FROM ALINITY HBSAG TO ALINITY S HBSAG; 2. PRODUCT CODE FROM KSJ TO QHM. UPDATE TO H6 METHOD CODE TO INCLUDE 4106 UPDATE TO THE INVESTIGATION: FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND SENSITIVITY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. THE CUSTOMER DECLINED TO SEND THE SAMPLE AT THIS TIME. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BOTH CLINICAL SEROCONVERSION PANELS AND IN-HOUSE SENSITIVITY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED. UPDATE: 16SEP2020 THE RETURN SAMPLE WAS TESTED WITH THE PRISM HBSAG CONFIRMATORY TEST ONLY, DUE TO LIMITED SAMPLE VOLUME PROVIDED BY THE CUSTOMER. THE CUSTOMER OBTAINED REPEAT REACTIVE RESULTS WITH PRISM HBSAG ASSAY, BUT NO TEST WITH PRISM HBSAG CONFIRMATORY HAD BEEN PERFORMED. ALINITY S HBSAG GAVE NONREACTIVE RESULTS AT THE CUSTOMER SITE. TESTING OF THE PRISM HBSAG CONFIRMATORY WAS PERFORMED TO SEE IF THE REPEAT REACTIVE RESULTS OBTAINED WITH PRISM HBSAG ASSAY ARE SPECIFIC TO HBSAG. THE SAMPLE WAS CONFIRMED POSITIVE WITH THE PRISM HBSAG CONFIRMATORY ASSAY. THEREFORE, DISCREPANT RESULTS WERE OBTAINED TO THE NONREACTIVE RESULTS OBTAINED BY THE CUSTOMER WITH ALINITY S HBSAG. THE OVERALL OUTCOME OF THE INITIAL INVESTIGATION DID NOT CHANGE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY S HBSAG REAGENT, LOT NUMBER 93169FN00.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND SENSITIVITY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. THE CUSTOMER DECLINED TO SEND THE SAMPLE AT THIS TIME. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BOTH CLINICAL SEROCONVERSION PANELS AND IN-HOUSE SENSITIVITY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ALINITY HBSAG, LIST 06P02-55, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST 06P02-60.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A (B)(6) HBSAG RESULT ON THE ALINITY S ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6). HBSAG PRISM INITIAL TEST: (B)(6), HBSAG PRISM RETEST 1: (B)(6), HBSAG PRISM RETEST 2: (B)(6), AHBC ARCHITECT: (B)(6), AHBS ARCHITECT: (B)(6), NAT CT HBV (ROCHE): (B)(6), VIRAL LOAD: (B)(6), ALINITY S HBSAG: (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791322 ALINITY S HBSAG HBSAG QHM ABBOTT IRELAND DIAGNOSTICS DIVISION 93169FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY S ANALYZER, LIST 06P16-01| ALINITY S ANALYZER, LIST 06P16-01| ALINITY S ANALYZER, LIST 06P16-01| SERIAL (B)(6) | SERIAL (B)(6) | SERIAL (B)(6)