BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1203152 · Received October 17, 2008

    Report

    Report Number
    2122870-2008-00331
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LEVELS OF QC TESTED PRIOR TO THE EVENT WERE WITHIN RANGE. THE SPECIMEN WAS PLASMA, COLLECTED INTO A BD HEPARIN TUBE WITHOUT GEL AND WAS CENTRIFUGED IN A STAT SPIN CENTRIFUGE FOR 3 MINUTES. TESTING OCCURRED FROM THE PRIMARY TUBE. CUSTOMER DID NOT QUESTION ANY OTHER SAMPLES AT THIS TIME. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: PER FSE, THE ISSUE WAS ISOLATED TO THE ONE PATIENT'S SAMPLE. THE FSE PERFORMED A DIAGNOSTIC TESTING AND OBTAINED ONE REPLICATE ELEVATED. THE FSE OBSERVED PERI-PUMP TUBING WAS GETTING STRETCHED OUT WHICH WAS REPLACED. "PER THE ACCESS SERVICE MANUAL, TESTS AND TROUBLESHOOTING SECTION: ISSUES WITH WORN PERI TUBING WOULD TYPICALLY CAUSE AN ELEVATED OUTLIER FOR A SANDWICH ASSAY. THE ACCESS BHCG ASSAY IS A SANDWICH ASSA". THE FSE PERFORMED QC. NO ADDITIONAL ISSUES NOTED TO DATE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSE NEGATIVE (-) TOTAL BHCG (TBHCG) RESULT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT FOR A SINGLE PATIENT SAMPLE. A PATIENT SAMPLE WAS TESTED FOR TBHCG AND A RESULT OF 0.35MIU/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER RE-TESTED THE ORIGINAL SAMPLE DILUTED AND BHCG RESULT WAS 2014.31 MIU/ML. AN AMENDED REPORT WAS SENT TO THE PHYSICIAN. THE CUSTOMER RE-TESTED (UNDILUTED AND DILUTED) SAMPLES ONCE MORE AND RESULTS WERE ">1000MIU/ML AND 2009.21MIU/ML RESPECTIVELY. NO EFFECT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA