BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 5074452 · Received September 14, 2015

    Report

    Report Number
    3008344661-2015-00025
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Report Date
    September 29, 2015
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, (B)(4), THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE US, (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    THERE WAS NO AVAILABLE PRODUCT FOR RETURN FOR THIS EVALUATION. CLINICAL SENSITIVITY OF REAGENT LOT 50515LF00 WAS ASSESSED USING AN IN-HOUSE RETAINED SAMPLE REAGENT KIT AGAINST A SET OF COMMERCIALLY AVAILABLE SEROCONVERSION PANELS. ALL RESULTS MET SPECIFICATIONS, INDICATING ACCEPTABLE PERFORMANCE OF THIS REAGENT LOT. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT (B)(6) ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. IN RELATION TO THE PROFILE OF MARKERS OBSERVED FOR THIS PATIENT: (B)(6) FOR (B)(6) AND ANTI-(B)(6) BUT (B)(6) FOR ANTI-(B)(6) AND TAKING INTO ACCOUNT THAT THE PATIENT WAS HISTORICALLY (B)(6) FOR (B)(6), IT IS POSSIBLE THAT THIS REPRESENTS A CASE OF OCCULT (B)(6) INFECTION. HOWEVER ADDITIONAL MARKER TESTING WOULD BE REQUIRED TO CONFIRM THIS. LITERATURE REVIEW IDENTIFIED A PUBLICATION WHICH PRESENTS LIKELY SEROLOGICAL PROFILES FOR OCCULT INFECTION ((B)(4)). 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 AS THE DISCREPANT RESULT WAS OBSERVED FOR A SINGLE PATIENT. PER PRODUCT LABELING, THE OVERALL SENSITIVITY WAS ESTIMATED TO BE (B)(4)% WITH A (B)(4)% CONFIDENCE INTERVAL OF (B)(4)% TO (B)(4)%.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT FROM THE YEAR 2010 THROUGH 2012, ONE PATIENT HAS GENERATED REACTIVE (B)(6) ASSAY RESULTS ON NON-ABBOTT PLATFORMS AS WELL AS ON THE ARCHITECT I2000SR ANALYZER. THE CURRENT SAMPLE FROM THIS PATIENT HAS GENERATED A (B)(6) RESULT. CONFIRMATORY TESTING IS (B)(6) AND THE PATIENT'S (B)(6) . LIVER ENZYMES AST AND ALT ARE WITHIN THEIR RESPECTIVE NORMAL REFERENCE RANGES. CURRENT SAMPLES FROM THIS PATIENT WERE SENT TO A REFERENCE LAB WHERE INITIAL (B)(6) RESULTS WERE (B)(6) AND CONFIRMATORY RESULTS WERE (B)(6) . (B)(6). THERE HAS BEEN NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605743 ARCHITECT HBSAG HBSAG KSJ ABBOTT IRELAND 50515LF00

    Patients

    Seq Age Sex Outcome Treatment
    1