BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 902648 · Received August 23, 2007

    Report

    Report Number
    2122870-2007-00199
    Event Type
    Other
    Date Received
    August 23, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 23, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFO, QC WAS WITHIN SPECS AT THE BEGINNING OF THE RUN. HOWEVER, ACTUAL QC DATA WAS NOT SUPPLIED. THE CUSTOMER NOTED SOME RESULTS WITH "NO VALUE AND SYS" FLAGS, AND THE EVENT LOG INDICATED VACUUM UNDER LIMITS ERRORS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND FOUND WASTE JUG FULL. THE FSE INSTALLED AN EMPTY WASTE JUG. THE FSE INSTALLED A NEW PIPETTOR TIP AND WASH TOWER INSERT. THE FSE PERFORMED ALIGNMENTS, PRIMED LINES TO VERIFY DISPENSE AND ASPIRATION OF FLUIDS. THE FSE CONDUCTED A DIAGNOSTIC TESTING. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. BASED ON AVAILABLE INFO, THE CUSTOMER HAD PLACED PAPER TOWELS UNDER THE WASTE JUG WHICH CAUSED THE WASTE SENSOR TO NOT FUNCTION PROPERLY. IN A FOLLOW-UP WITH THE CUSTOMER, THEY HAVE NOT HAD ANY FURTHER ISSUES IN REGARDS TO THIS EVENT. HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR 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 FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. THE INITIAL PSA RESULT WAS 0.00NG/ML. THE RESULTS WAS NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RETESTED FOR PSA AND THE REPEATED RESULT WAS HIGHER: 4.59NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION, OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR