BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 6015986 · Received October 10, 2016

    Report

    Report Number
    3008344661-2016-00063
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 2, 2016
    Report Date
    June 1, 2017
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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, LIST NUMBER 02G22, THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE US, LIST NUMBERS 01L80 AND 04P53.

    Additional Manufacturer Narrative · 1

    CUSTOMER FIELD DATA WAS USED TO ASSESS THE SPECIFICITY OF THE ASSAY. REPORT DATA WAS REVIEWED COVERING THE TIMEFRAME FROM 01 NOVEMBER 2015 TO 29 OCTOBER 2016. THE REPORT SHOWS THAT ACROSS LOTS WITH 46,557,089 PATIENT TEST RESULTS, THE RANGE OF MEDIAN RESULTS IS 0.150749 TO 0.230994 S/CO. THE OVERALL MEDIAN RESULT ACROSS ALL REAGENT LOTS IS 0.182119 S/CO. THE MEDIAN PATIENT RESULT FOR LIKELY CAUSE LOT 61560FN00 IS 0.161393 S/CO (BASED ON 1,069,127 RESULTS), WHICH INDICATES THAT THE LOT IS PERFORMING ACCEPTABLY AND COMPARABLE TO OTHER LOTS IN THE FIELD. NO RETURNS WERE AVAILABLE FOR TESTING FROM THE CUSTOMER SITE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THERE WERE NO NON STATISTICAL OR ADVERSE TRENDS FOR THE ISSUE NOTED. THE ARCHITECT HBSAG QUALITATIVE II ASSAY PACKAGE INSERT AND THE ARCHITECT OPERATION MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE ISSUE INVOLVED A SINGLE DISCREET PATIENT SAMPLE. THE REASON FOR THIS DISCREPANT RESULT FOR THIS PATIENT IS UNCLEAR BUT MAY BE DUE TO SAMPLE/REAGENT INTEGRITY OR INSTRUMENT ISSUES.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED; THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AND THE EVALUATION CODES WERE CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION FOR ONE MALE PATIENT: (B)(6). THE PATIENT HAS HAD NO RECENT VACCINATIONS (LAST ONE IN 2013) AND NO CLINICAL SYMPTOMS OF A (B)(6). THIS PATIENT WAS ALSO TESTED WITH THE ROCHE METHODOLOGY AND GENERATED (B)(6) RESULTS FOR THE HBSAG, ANTI-HBS AND ANTI-HBC ASSAYS. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666355 ARCHITECT HBSAG QUALITATIVE II HBSAG KSJ ABBOTT IRELAND 61560FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 SN: (B)(4)