BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT

    MDR report key: 2071895 · Received April 28, 2011

    Report

    Report Number
    1415939-2011-00136
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 20, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT 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 (B)(6) AND (B)(4) 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 (B)(4) INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED FALSELY ELEVATED B-HCG RESULTS FOR THREE 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 TOTAL B-HCG REAGENT FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT LABORATORIES 81919JN00

    Patients

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