BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 6202248 · Received December 23, 2016

    Report

    Report Number
    3008344661-2016-00078
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 26, 2016
    Report Date
    June 7, 2017
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AT THE CUSTOMER SITE. HOWEVER, NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS IDENTIFIED. THE CONCLUSION CODE IN EVALUATION CODES WAS CHANGED FROM (B)(4).

    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 SIMILAR PRODUCTS DISTRIBUTED IN THE US, LIST NUMBERS (B)(4).

    Additional Manufacturer Narrative · 1

    HISTORICAL COMPLAINT SEARCHES DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR THE CUSTOMER ISSUE. NO NON STATISTICAL OR ADVERSE TREND FOR THE ISSUE WAS IDENTIFIED. HISTORICAL PERFORMANCE OF THE REAGENT LOT WAS EVALUATED USING WORLD WIDE DATA FROM ABBOTT LINK. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THIS LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS WHICH INDICATES THAT THE LOT IS PERFORMING ACCEPTABLY AND COMPARABLE TO OTHER LOTS IN THE FIELD. TESTING OF PANELS WHICH MIMIC PATIENT SAMPLES USING IN-HOUSE RETAINED KITS WAS PERFORMED. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO PRODUCT MALFUNCTION OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT REPEAT REACTIVE ARCHITECT HBSAG QUALITATIVE II RESULTS WERE GENERATED FOR A SERUM SAMPLE FROM A PATIENT ON (B)(6) 2016. THE REACTIVE RESULTS WERE CONFIRMED USING THE ARCHITECT HBSAG CONFIRMATORY ASSAY. SINCE ANTI-HBS WAS ALSO REACTIVE, HBSAG TESTING WAS REPEATED ON (B)(6) 2016 FOR THE SAME PATIENT AND DISCREPANT NONREACTIVE RESULTS WERE OBSERVED. THE HBSAG RESULTS ARE SUSPECTED TO BE FALSELY REACTIVE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851801 ARCHITECT HBSAG QUALITATIVE II HBSAG KSJ ABBOTT IRELAND 63202FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST (B)(4), SERIAL (B)(4)