BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1883286 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01098
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAPPENED ON (B)(6) 2010, BUT WAS NOT REPORTED TO BCI UNTIL 09/27/2010. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE EVENT. THE SAMPLE IS NOT AVAILABLE FOR RERUN. A SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY HIGH GLUCOSE (GLU) RESULT OF 79 MG/DL GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM FOR ONE NEONATE PATIENT. TESTING BY AN ALTERNATE METHOD ON TWO DIFFERENT SAMPLES OF THE PATIENT PRODUCED 29 AND 30 MG/DL, WHICH THE PHYSICIAN BELIEVED. THE PATIENT TREATMENT WAS DELAYED DUE TO THE DISCREPANCY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other