BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY

    MDR report key: 5994137 · Received October 3, 2016

    Report

    Report Number
    3008344661-2016-00061
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 10, 2016
    Report Date
    June 1, 2017
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CUSTOMER DOES NOT RUN THE ARCHITECT HAVAB IGG ASSAY ON THEIR ANALYZER. THEREFORE, THE POSSIBILITY OF FALSE REACTIVE RESULTS DUE TO REAGENT MEDIATED CARRYOVER IS RULED OUT. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED SAMPLE OF THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY, LOT 61161FN00. 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. THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL BOTH 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 DISCREPANT RESULTS FROM A SINGLE DISCREET PATIENT SAMPLE. ADDITIONAL TESTING OF A NEW SAMPLE GENERATED EXPECTED (B)(6) RESULTS. THE ISSUE MAY HAVE BEEN THE RESULT OF SAMPLE/REAGENT HANDLING OR INTEGRITY.

    Additional Manufacturer Narrative · 1

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

    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 02G23, THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE US, LIST NUMBERS 01L81 AND 04P54.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT ONE DIALYSIS PATIENT GENERATED INITIAL (B)(6) ARCHITECT (B)(6) RESULTS OF (B)(6) WITH NEUTRALIZING CONFIRMATORY RESULTS OF (B)(6) NEUTRALIZATION ON (B)(6) 2016. RESULTS FOR (B)(6) WERE (B)(6). THE PATIENT RETURNED ON (B)(6) 2016 AND A NEW SAMPLE WAS DRAWN THAT GENERATED AN INITIAL ARCHITECT (B)(6) RESULT OF (B)(6). THE CUSTOMER PROCEEDED TO TEST THE SAMPLE WITH THE (B)(6), WHICH GENERATED NON-CONFIRMING RESULTS. THIS SECOND SAMPLE WAS ALSO (B)(6). THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645919 ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY HBSAG CONFIRMATORY KSJ ABBOTT IRELAND 1161FN00

    Patients

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