BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA CLINICAL ANALYZER

    MDR report key: 2152338 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02456
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    November 28, 2008
    Report Date
    December 5, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K881495
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED TO THE SITE SINCE ONE WAS NOT REQUESTED BY THE CUSTOMER. THE PROBLEM WAS RESOLVED BY RECALIBRATION OF THE SYSTEM BY THE CUSTOMER. SINCE THE MANUFACTURER (BCI) DID NOT EVALUATE OR TEST THE SYSTEM, A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THIS IS 1 OF 11 INDIVIDUAL MEDWATCH REPORTS WHICH ARE RELATED TO THIS EVENT. THE RELATED MDRS ARE AS FOLLOWS: 2050012-2011-02182, 02451, 02452, 02453, 02454, 02455, 02457, 02458, 02459, 02460. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR SYNCHRON CX5 DELTA CLINICAL ANALYZER INSTRUMENT AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS CALIBRATED AND THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. SEVERAL HOURS INTO ROUTINE OPERATION OF THE ANALYZER, LOW NA RESULTS WERE PRODUCED, REPORTED OUT AND LATER QUESTIONED BY THE MEDICAL STAFF. THE CUSTOMER RECALIBRATED THE ISE SYSTEM AND PERFORMED QC RUNS BEFORE REPEATING ANALYSIS OF THE PATIENT SAMPLES AND HIGHER NA RESULTS WERE OBTAINED FOR SEVERAL SAMPLES. ELEVEN (11) AMENDED RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER ONLY PROVIDED THREE (3) OUT OF THE ELEVEN (11) RESULTS AS EXAMPLES OF THE SAMPLE DATA. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS NOT KNOWN IF THERE WAS ANY MODIFICATION TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 DELTA CLINICAL ANALYZER JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK