BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 2070783 · Received April 27, 2011

    Report

    Report Number
    1628664-2011-00195
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    June 8, 2010
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    DHA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT FALSELY ELEVATED B-HCG RESULTS OCCURRED DUE TO CARRYOVER ON THE ARCHITECT I1000SR PLATFORM WHEN THE FOLLOWING THREE STEPS OCCUR: 1-RUBELLA ANCILLARY DILUENT HAS BEEN ASPIRATED BY THE REAGENT PROBE 2-A HIGH CONCENTRATION B-HCG SAMPLE IS THEN ASPIRATED BY THE REAGENT PROBE 3-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. THE CAUSATIVE AGENT OF THE FALSELY ELEVATED RESULTS FOR THE NEGATIVE B-HCG SAMPLES ON THE I10000SR IS THE POLY SODIUM 4-STYRENE-SULFONATE COMPONENT OF THE ARCHITECT RUBELLA IGG ASSAY SPECIFIC DILUENT. THIS COMPONENT CAUSES REAGENT MEDIATED SAMPLE CARRYOVER OF B-HCG INTO B-HCG NEGATIVE SAMPLES. 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.

    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 (B)(4)) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER (B)(4)) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED FALSELY ELEVATED B-HCG RESULTS FOR FIVE PATIENT SAMPLES. DATA WAS REVIEWED AND FOUND NOT TO AFFECT THE CLINICAL INTERPRETATION OR MEDICAL DECISION MAKING. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER DHA ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1