BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2093188 · Received May 18, 2011

    Report

    Report Number
    1415939-2011-00150
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LN 7K78, ARCHITECT TOTAL B-HCG, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LN 6C21, ARCHITECT TOTAL B-HCG. 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. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED A FALSELY ELEVATED B-HCG RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED B-HCG RESULTS OF 10.97, <1.2, <1.2, AND 22.74. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL B-HCG FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT LABORATORIES 89908JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARCH I1000SR LN 01L86-01 SN (B)(6) | ARCH I1000SR LN 1L86-01 SN (B)(4)