BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 6606444 · Received June 1, 2017

    Report

    Report Number
    3005094123-2017-00035
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Report Date
    July 18, 2017
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING REPORT 3005094123-2017-00035 FOR THIS PRODUCT SHOULD BE ABBOTT IRELAND AND NOT A.I.D.D. LONGFORD. MDR 3008344661-2017-00068 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, LABELING REVIEW, DEVICE HISTORY REVIEW, FIELD DATA REVIEW, AND SPECIFICITY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. HISTORICAL PERFORMANCE OF THE REAGENT LOT WAS EVALUATED USING WORLD WIDE DATA FROM ABBOTT LINK. THE PATIENT DATA AND CALIBRATOR DATA WERE ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULTS AND CALIBRATOR RESULTS FOR THIS LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS AND NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. THE PRODUCT AND PATIENT SAMPLE WERE NOT AVAILABLE FOR RETURN. 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. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY REACTIVE HBSAG RESULTS WHILE USING THE ARCHITECT HBSAG REAGENTS. THE FOLLOWING DATA WAS PROVIDED. INITIAL 0.20 IU/ML (REACTIVE), NO REPEAT VALUES WERE PROVIDED. CONFIRMATION TEST WAS POSITIVE. OTHER TESTS, INCLUDING HBEAG AND HBSAB WERE NEGATIVE. PREVIOUS RESULTS WERE 0.00 (NEGATIVE) IN (B)(6) 2016, HOWEVER THE SPECIFIC METHOD USED WAS NOT PROVIDED. THE PATIENT RECEIVED A BLOOD TRANSFUSION IN (B)(6) 2016, HOWEVER NO OTHER INFORMATION WAS PROVIDED RELATED TO TEST RESULTS OF THE TRANSFUSED BLOOD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387274 ARCHITECT HBSAG HBSAG KSJ A.I.D.D LONGFORD 69053FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR