BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 6026499 · Received October 13, 2016

    Report

    Report Number
    3008344661-2016-00064
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    May 1, 2017
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    P050051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THE DEVICE DID NOT PERFORM AS INTENDED. HOWEVER, NO SYSTEMATIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND SPECIFICITY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PATIENT SAMPLE WAS AVAILABLE FOR RETURN, THEREFORE CLINICAL SPECIFICITY TESTING OF NEGATIVE CONTROL REPLICATES WAS PERFORMED USING IN-HOUSE RETAINED KITS STORED AT THE RECOMMENDED STORAGE CONDITION. SPECIFICITY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND 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, LIST NUMBER (B)(4), THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY REACTIVE ANTI-HBS RESULTS WHILE USING THE ARCHITECT ANTI-HBS REAGENTS. THE FOLLOWING DATA WAS PROVIDED (MIU/ML) FOR ONE PATIENT. INITIAL 10.6 (REACTIVE) A PREVIOUS RESULT FOR THE SAME PATIENT WAS 6.0 (NONREACTIVE). ADDITIONALLY, (B)(6) RESULTS WERE OBTAINED FOR HBSAG AND HBC ANTIBODY, HOWEVER THE SPECIFIC METHOD AND VALUES WERE NOT PROVIDED AND THE CUSTOMER DID NOT ALLEGE DISCREPANT RESULT FOR EITHER HBSAG OR HBC. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678229 ARCHITECT ANTI-HBS ANTI-HBS LOM ABBOTT IRELAND 63029FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LIST NUMBER (B)(4)| SERIAL NUMBER (B)(4)