BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 3004650 · Received March 14, 2013

    Report

    Report Number
    3005094123-2013-00024
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. WITH A UNIQUE COMBINATION OF INSTRUMENT AND REAGENT CONDITIONS THERE IS A POTENTIAL FOR SAMPLE CARRYOVER WHICH CAN RESULT IN FALSELY ELEVATED B-HCG CONCENTRATIONS ON THE ARCHITECT I1000SR SYSTEM. NEGATIVE SAMPLES HAVE RETURNED BOTH POSITIVE AND GREY ZONE B-HCG RESULTS WHEN A HIGH CONCENTRATION B-HCG SAMPLE IS ASSESSED PRIOR TO THE NEGATIVE SAMPLE WITH ARCHITECT TOTAL B-HCG (LIST NUMBER 7K78/6C21) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY AND/OR THE ARCHITECT HAVAB-IGG ASSAY (LIST NUMBER 6C29). THIS OCCURS DUE TO REAGENT MEDIATED SAMPLE CARRYOVER OF HIGH B-HCG SAMPLES CAUSED BY THE ARCHITECT RUBELLA IGG ASSAY SPECIFIC DILUENT COMPONENT OR THE ARCHITECT HAVAB-IGG MICORPARTICLE COMPONENT ON AN ARCHITECT I1000SR SYSTEM. ARCHITECT RUBELLA IGG IS CURRENTLY BEING REFORMULATED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED A FALSE POSITIVE BHCG RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL BHCG RESULT OF 30.54 AND A REPEAT RESULT OF <1.2 MIU/ML. THE FALSELY ELEVATED BHCG RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107894 ARCHITECT TOTAL B-HCG DHA A.I.D.D LONGFORD 21912JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR ARCHITECT I1000SR ANALYZER| LN 01L86-01 SN (B)(4)