BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 5041419 · Received August 30, 2015

    Report

    Report Number
    3002809144-2015-00058
    Event Type
    Malfunction
    Date Received
    August 30, 2015
    Date of Event
    June 1, 2015
    Report Date
    October 1, 2015
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZO
    PMA / PMN Number
    P050042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CUSTOMER RETURNS WERE AVAILABLE FOR TESTING. A RETAINED KIT OF ARCHITECT (B)(6) REAGENT, LOT NUMBER 52283LI00, WAS TESTED TO EVALUATE SENSITIVITY. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. TWO SENSITIVITY PANELS (PANEL A AND PANEL B) AND THE (B)(6) CONTROL WERE TESTED. THE MEAN S/CO OF THE SENSITIVITY PANEL VALUES AND (B)(6) CONTROL VALUES MET SPECIFICATIONS AND ALL GENERATED RESULTS WERE IN THE TYPICAL RANGE AND NO (B)(6) RESULTS WERE OBTAINED. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX (B)(6)) ON ONE INSTRUMENT. THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT (B)(6) TEST RESULTS PROVIDED BY ZEPTOMETRIX. THE REAGENT DETECTED THE SAME BLEEDS AS REACTIVE WITH COMPARABLE S/CO VALUES FOR THE SEROCONVERSION PANELS. QUALITY METRICS WERE REVIEWED. NO NON-STATISTICAL OR ADVERSE TREND WAS IDENTIFIED FOR THE ISSUE UNDER REVIEW. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS ADEQUATELY ADDRESSED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED DATA GENERATED WHILE EVALUATING SPECIFICITY OF THE ARCHITECT ANTI-(B)(4) ASSAY. ONE PATIENT SAMPLE WAS FOUND TO BE (B)(6) WITH THE ARCHITECT (B)(4) ASSAY ON (B)(6) 2015 BUT (B)(6) AT ANOTHER LABORATORY. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574263 ARCHITECT ANTI-HCV ANTI-HCV MZO ABBOTT GERMANY 52283LI00

    Patients

    Seq Age Sex Outcome Treatment
    1