BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 2073360 · Received May 1, 2011

    Report

    Report Number
    2050012-2011-01368
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE SERUM. QC AND CALIBRATION WERE RUNNING WITHIN ESTABLISHED SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT AND REPLACED THE GLUCOSE REAGENT SYRINGE AND THE MODULE. ALTHOUGH SERVICE REPLACED HARDWARE, THE ROOT CAUSE IS UNKNOWN AT THIS TIME FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING TWO (2) ERRONEOUSLY HIGH GLUCOSE (GLUCM) PATIENT RESULTS WHEN RUNNING IN DUPLICATE MODE THAT WERE GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM. ONE OF THE TWO PATIENT'S ORIGINAL AND REPEAT GLUCM RESULTS READ 168 MG/DL AND 93 MG/DL, RESPECTIVELY. THE OTHER PATIENT'S ORIGINAL AND REPEAT GLUCM RESULTS READ 142 MG/DL AND 125 MG/DL, RESPECTIVELY. IT IS UNKNOWN WHICH RESULTS WERE ACTUALLY REPORTED FOR BOTH PATIENTS. PER THE CUSTOMER, PRIOR TO THE EVENT THE GLUCOSE ELECTRODE HAD BEEN REPLACED. PATIENT TREATMENT WAS NOT AFFECTED IN REGARD TO THIS EVENT AS THE CUSTOMER RUNS ALL GLUCOSE SAMPLES IN DUPLICATE MODE AND VERIFIES THE RESULTS PRIOR TO REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX® I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. LX®I 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1