BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2060389 · Received April 15, 2011

    Report

    Report Number
    2050012-2011-01166
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE SAMPLE IS A "TURBID" LOOKING SAMPLE. SERUM INDICES NOT IDENTIFIED BY THE CUSTOMER. CUSTOMER DID NOT MENTION PROBLEMS WITH CALIBRATION OR QC. THIS IS A SAMPLE SPECIFIC EVENT. NO FURTHER INVESTIGATION OF THIS SAMPLE WAS DONE BY THE CUSTOMER. SERVICE WAS NOT REQUESTED OR GENERATED. ROOT CAUSE IS UNKNOWN FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ONE GLUCOSE (GLUCM) "TURBID" LOOKING PATIENT SAMPLE THAT WOULD NOT MATCH WHEN RUN IN DUPLICATE MODE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT. CUSTOMER RUNS IN DUPLICATE MODE AND VERIFIES THE RESULT PRIOR TO REPORTING. TWO (2) OTHER INSTRUMENT ENCOUNTERED THE SAME ISSUE. MDR # 2050012-2011-01161 AND 2050012-2011-01167 DOCUMENTS THE REPORTABLE EVENT FOR THE OTHER TWO (2) INSTRUMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1