BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2325811 · Received November 6, 2011

    Report

    Report Number
    3005094123-2011-00520
    Event Type
    Malfunction
    Date Received
    November 6, 2011
    Report Date
    September 7, 2011
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE INVESTIGATION DETERMINED THAT FALSELY ELEVATED B-HCG RESULTS OCCURRED DUE TO CARRYOVER ON THE ARCHITECT I1000SR PLATFORM WHEN THE FOLLOWING THREE STEPS OCCUR: RUBELLA ANCILLARY DILUENT HAS BEEN ASPIRATED BY THE REAGENT PROBE; A HIGH CONCENTRATION B-HCG SAMPLE IS THEN ASPIRATED BY THE REAGENT PROBE; REAGENT PROBE ASPIRATES A NEGATIVE SAMPLE OR B-HCG CONJUGATE FOLLOWED BY A B-HCG NEGATIVE SAMPLE. CARRYOVER ON THE ARCHITECT I1000SR ONLY OCCURS WHEN A HIGH CONCENTRATION B-HCG SAMPLE IS ASPIRATED AFTER THE ARCHITECT RUBELLA IGG (LN 6C17) ASSAY ANCILLARY DILUENT. (B)(4). CARRYOVER WAS ONLY OBSERVED ON THE ARCHITECT I1000 PLATFORM SERIES. REFORMULATION OF THE ARCHITECT RUBELLA IGG/ARCHITECT B-HCG ASSAYS WILL BE EVALUATED TO MITIGATE AGAINST THIS COMPONENT BINDING AND CARRYING HIGH B-HCG SAMPLES INTO LOW OR NEGATIVE B-HCG SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT DISCREPANT RESULTS WERE GENERATED OVER A TWO HOUR PERIOD ON ONE PATIENT SAMPLE WITH THE ARCHITECT TOTAL BPHCG ASSAY: 8.54, 2.38, <7000 (476), <1.20 (0.88), <1.20 (0.70), <1.20 (0.75), <7000 (1.33), 19.05, 17.96, AND 8.14 MIU/ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I1000SR LN 01L86-01 SN (B)(4)