BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1914624 · Received December 3, 2010

    Report

    Report Number
    2050012-2010-01516
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    LEVEL III QC RECOVERY WAS ERRATIC IN THE AM SHIFT. CUSTOMER RECALIBRATED GLUCOSE MODULE AND RERAN ALL SAMPLES PRIOR TO ERRATIC QC RECOVERY. SERVICE CALL WAS INITIATED AND PHONE CALLS WERE PERFORMED WITH THE CUSTOMER. CUSTOMER RECALIBRATED THE ELECTRODE AND RECALIBRATED THE GLUCOSE MODULE. HOWEVER, THEY STILL WERE SEEING ERRATIC RECOVERY. CUSTOMER CHANGED THE REAGENT BOTTLE AND RECALIBRATED, BUT IT DID NOT RESOLVE THE ISSUE. CUSTOMER CHANGED TO A NEW ELECTRODE. AS OF (B)(6) 2010, NO NEW REPORTS OF ANY GLUCOSE PROBLEMS WERE RECEIVED. A ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW GLUCOSE (GLUM) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR FIVE PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLES WERE RE-TESTED AND HIGHER GLUM RESULTS WERE OBTAINED FOR ALL FIVE PATIENTS. RESULTS WERE AMENDED. CUSTOMER IS UNAWARE OF ANY CHANGE IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1