BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX CLINICAL SYSTEM

    MDR report key: 2183598 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-01648
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    November 2, 2009
    Report Date
    November 2, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K950958
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED TO THE SITE SINCE ONE WAS NOT REQUESTED BY THE CUSTOMER. THE BCI HOTLINE INSTRUCTED THE CUSTOMER ON HOW TO REPLACE THE NA ELECTRODE AND THIS ALLEVIATED THE PROBLEM. HOWEVER, A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THIS IS 1 OF 50 MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS IS 1 OF 50 PATIENT RESULTS RELATED TO THIS EVENT. ALL ASSOCIATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT ARE LISTED BELOW: 2050012-2011-02447, 02449, 02450, 02858, 02859, 02860, 02861, 02862, 02863, 02864, 02865, 02866, 02867, 02868, 02869, 02870, 02871, 02872, 02873, 02874, 02875, 02876, 02877, 02878, 02879, 02925, 02926, 02927, 02928, 02929, 02930, 02931, 02932, 02933, 02934, 02935, 02937, 02939, 02940, 02941, 02942, 02943, 02944, 02945, 02946, 02947, 02948, 02949.

    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 CX9 ALX CLINICAL SYSTEM INSTRUMENT, AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS CALIBRATED SUCCESSFULLY AND THE NA QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGE. WHEN THE OPERATOR NOTICED THAT MANY NA RESULTS WERE LOW, THE ISE SYSTEM WAS RECALIBRATED AND QC RUN AGAIN. THE CUSTOMER RE-RAN THE PATIENT SAMPLES, FOUND THAT THE RESULTS WERE HIGHER AND ISSUED AMENDED REPORTS. THE CUSTOMER PROVIDED 50 ERRONEOUSLY LOW NA RESULTS ALONG WITH THE CORRECTED RESULTS. WHILE THE CUSTOMER DID NOT RECEIVE ANY REPORT OF ANY ADVERSE EVENT OR INJURY ASSOCIATED WITH THIS EVENT, IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK