BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1003402 · Received February 13, 2008

    Report

    Report Number
    2122870-2008-00058
    Event Type
    Malfunction
    Date Received
    February 13, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON DATA PROVIDED, QC WAS WITHIN SPECIFICATIONS. THE LAST SYSTEM CHECK WAS PERFORMED IN 2008 AND PASSED SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSA PERFORMED HARDWARE VERIFICATION, AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. 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 AN ERRONEOUSLY LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. A PT SAMPLE WAS TESTED FOR PSA AND A RESULT OF 1.6 NG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED AS THIS PT HAD A PREVIOUS PSA RESULT OF 9.1 NG/ML 2 MONTHS AGO. THE CUSTOMER RE-TESTED THE ORIGINAL SAMPLE FOR PSA AND REPEATED RESULT WAS 8.41 NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA