BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2112096 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01674
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. HYB-PSA QC WAS PASSING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. A ROUTINE SYSTEM CHECK RESULTS WERE "GOOD". THE DATE OF THE SYSTEM CHECK WAS NOT SUPPLIED. CUSTOMER SENT SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) EAST FOR ADDITIONAL TESTING. THE CPLS EAST TESTING DID NOT IDENTIFY ANY SAMPLE INTERFERENTS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM GENERATED A HYBRITECH PROSTATE-SPECIFIC ANTIGEN (HYB-PSA) RESULT WITHIN THE NORMAL REFERENCE RANGE FOR ONE (1) PATIENT. THIS RESULT WAS DISCORDANT TO ANOTHER METHODOLOGY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LTJ BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR