BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 6075201 · Received November 3, 2016

    Report

    Report Number
    3008344661-2016-00069
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    May 29, 2017
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW WAS CONDUCTED OF THE CUSTOMER'S INSTRUMENT RESULT LOGS, WHICH SHOWED SAMPLES ID (B)(6) WERE TESTED USING THE ARCHITECT (B)(4) QUALITATIVE II AND ARCHITECT (B)(4)QUALITATIVE II CONFIRMATORY ASSAYS ON (B)(6) 2016 AND GAVE LOW (B)(6) RESULTS OF (B)(6) AT FOUR DIFFERENT TEST POINTS WITH A (B)(6) RESULT OF (B)(6) OBTAINED FOR ONE TEST POINT. DATA REVIEW CONFIRMS THE SAMPLE WAS TESTED TWICE USING THE ARCHITECT (B)(4) QII CONFIRMATORY ASSAY WITH CONFIRMED (B)(6). THE SAMPLE WAS (B)(6). A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. AS NO PATIENT SAMPLES WERE AVAILABLE TO ASSIST IN THE INVESTIGATION, CLINICAL SENSITIVITY TESTING WAS PERFORMED USING SEROCONVERSION PANELS, WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT OF REAGENT LOT 63202FN00. 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 (B)(4) QUALITATIVE II REAGENT PACKAGE INSERT CONTAINS 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 OCCURRED FOR ONE DISCRETE SERUM SAMPLE.

    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 02G22, THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE US, LIST NUMBERS 01L80 AND 04P53.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS DISCREPANT ARCHITECT (B)(4) QUAL II ASSAY RESULTS FOR ONE PATIENT BETWEEN THE SERUM AND PLASMA SAMPLES COLLECTED AT THE SAME DRAW. THE FOLLOWING WAS PROVIDED: INITIAL EDTA PLASMA SAMPLE (B)(6). THE SAMPLE WAS RETESTED IN DUPLICATE AND GENERATED (B)(6) RESULT OF APPROXIMATELY (B)(6). THE SAMPLE CONFIRMED WITH THE ARCHITECT (B)(4) QUAL II CONFIRMATORY ASSAY AT 90%. INITIAL SERUM SAMPLE (B)(6). THE CUSTOMER DID NOT RETEST THE SAMPLE IN DUPLICATE BUT WENT TO TESTING THE SAMPLE WITH THE ARCHITECT (B)(4) QUAL II CONFIRMATORY ASSAY, WHICH CONFIRMED AT 70%. THE SAMPLES TESTED NOT PROTECTED (NEGATIVE) WITH THE ARCHITECT (B)(4) ASSAY. CLINICAL HISTORY ON THIS PATIENT IS UNKNOWN. THE SAMPLES WERE NOT TESTED BY ANY OTHER METHODS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727751 ARCHITECT HBSAG QUALITATIVE II HBSAG KSJ ABBOTT IRELAND 63202FN00

    Patients

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