BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXC 600I

    MDR report key: 2061464 · Received April 18, 2011

    Report

    Report Number
    2122870-2011-01015
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A 13X100 GREINER VACUETTE SERUM TUBE, STORED AT ROOM TEMPERATURE, AND CENTRIFUGED AT 3500 RCF FOR 10 MINUTES AT 20C. QC IS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. SYSTEM CHECK DATA HAS NOT BEEN SUPPLIED TO DATE. SERVICE HAS NOT BEEN DISPATCHED IN CONNECTION WITH THIS EVENT TO DATE. AN APPLICATIONS SPECIALIST CONTACTED THE LAB TO DETERMINE THE "HEALTH OF THE INSTRUMENT." 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) TO REPORT HIGHER THAN EXPECTED ACCUTNI RESULT ABOVE THE AMI CUTOFF FOR ONE (1) MALE PATIENT. SUBSEQUENT TESTING OF THE SAMPLE PRODUCED LOWER RESULTS BUT STILL ABOVE THE AMI CUTOFF. THE RESULTS WERE NOT MEETING ACCUTNI PRECISION SPECIFICATIONS ON THE ACCESS 2. 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 DXC 600I CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR