BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2030072 · Received March 25, 2011

    Report

    Report Number
    2122870-2011-00808
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2011 AND MET SPECIFICATIONS. SERVICE WAS ON SITE (B)(4) 2011 AND VERIFIED THE ALIGNMENTS WERE WITHIN THE SPECIFICATIONS. A SYSTEM CHECK, HS SYSTEM CHECK, CARRYOVER AND PRECISION TESTS WERE PERFORMED AND ALL MET SPECIFICATIONS. NO HARDWARE ISSUES WERE ADDRESSED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. NO CLEAR ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A VITAMIN B12 RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED ON UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT'S SAMPLE. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL PICTURES, AND WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON AN ALTERNATE DXI 800 INSTRUMENT PRODUCED A RESULT IN THE NORMAL REFERENCE RANGE. 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1