BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT

    MDR report key: 2093047 · Received May 18, 2011

    Report

    Report Number
    1415939-2011-00146
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DHA
    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 12.32, 12.22, <7000 AND 25.71. THE DISCREPANT RESULTS WERE 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
    1 ARCHITECT TOTAL B-HCG REAGENT FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT LABORATORIES 94908JN00

    Patients

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