BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 3001772 · Received March 13, 2013

    Report

    Report Number
    3005094123-2013-00022
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 12, 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 FALSE POSITIVE BHCG RESULTS FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED INITIAL BHCG RESULTS OF 58.4 AND 65.19 MIU/ML. THE SAMPLE WAS REPEATED USING SAVONNETTE RAPID TEST AND AN UNKNOWN METHOD AT ANOTHER LABORATORY. BOTH TESTS GENERATED NEGATIVE BHCG RESULTS. THE SAMPLE WAS TESTED IN AN HBT TUBE AND A BHCG RESULT OF 16.58 MIU/ML WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105339 ARCHITECT TOTAL B-HCG DHA A.I.D.D LONGFORD 21912JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR ARCHITECT I1000SR ANALYZER 1L86-01| SN (B)(4)