BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    MDR report key: 2092304 · Received May 18, 2011

    Report

    Report Number
    2122870-2011-01429
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC SAMPLE INFORMATION HAS NOT BEEN SUPPLIED TO DATE. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. SYSTEM CHECK DATA HAS NOT BEEN SUPPLIED TO DATE. SERVICE WAS OFFERED TO THE CUSTOMER AT THE TIME OF CONTACT BUT SERVICE WAS DECLINED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY HIGH CREATININE KINASE - MB (CKMB) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE (1) PATIENT THAT WAS GENERATED BY THE UNICEL DXC 600I ACCESS IMMUNOASSAY SYSTEM. REPEAT TESTING OF THE SAMPLE PRODUCED LOWER RESULTS WAS STILL ABOVE THE NORMAL REFERENCE RANGE BUT OUTSIDE OF THE ASSAY PRECISION LIMITS OF 8%. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. 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® DXC 600I ACCESS® IMMUNOASSAY SYSTEM. DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1