BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRON CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2001284 · Received February 24, 2011

    Report

    Report Number
    2050012-2011-00544
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE ARE IN PLASMA TUBE WHICH WERE SPUN FOR 10 MINUTES AND POURED INTO AN INSERT CUP. SAMPLE WAS SLIGHTLY ICTERIC. PER CUSTOMER, QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. THIS IS A SAMPLE SPECIFIC EVENT; THEREFORE, SERVICE CALL WAS NOT GENERATED OR INITIATED. A CLEAR ROOT CAUSE IS UNKNOWN FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOW GLUCOSE (GLU) CARTRIDGE RESULT GENERATED BY SYNCHRON CX5 DELTA CLINICAL SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY; HENCE NO PATIENT TREATMENT WAS IMPACTED. THE ORIGINAL SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. IN ADDITION, THE SAMPLE WAS RUN ON SYNCHRON CX9 PRO CLINICAL SYSTEM AND GLUCOSE MODULAR RESULT WAS 45 MG/DL. THE SAMPLE WAS REPEATED AND A RESULT OF 47 MG/DL WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC CX 5 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1