BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2260102 · Received August 26, 2011

    Report

    Report Number
    2050012-2011-04121
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    December 15, 2008
    Report Date
    December 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE SITE ON (B)(4) 2008 AND PERFORMED TROUBLESHOOTING ON THE SYSTEM. THE FSE REPLACED THE EIC (ELECTROLYTE INJECTION CUP) ASSEMBLY, THE RATIO PUMP, THE PRE-AMP BOARD AND THE MC (MODULAR CHEMISTRY) SAMPLE PROBE. THE MC PROBE WAS ALIGNED CORRECTLY. HOWEVER, PROBLEMS WITH LOW ISE RESULTS CONTINUED AND THE FSE RETURNED TO THE SITE ON (B)(4) 2008 AND PERFORMED A DECONTAMINATION AND CULTURE OF THE ISE SYSTEM. ON (B)(4) 2008, THERE WAS NO EVIDENCE OF BACTERIAL GROWTH ON THE CULTURE AND THE CUSTOMER WAS SATISFIED THAT THE ISE WAS PERFORMING WITHIN SPECIFICATIONS. WHILE THESE MEASURES RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE FOR THE EVENT WAS NOT DETERMINED. THIS IS 1 OF 100 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 ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) AND CHLORINE (CL) RESULTS WERE OBTAINED OUT OF RANGE LOW ON THEIR UNICEL DXC 800 SYNCHRON SYSTEM INSTRUMENT, AND THIS WAS AN INTERMITTENT ISSUE SINCE 12/15/2008. HOWEVER, THE POTASSIUM (K) RESULTS WERE WITHIN THE ACCEPTABLE RANGE. PRIOR TO THE EVENT, THE NA AND CL QC (QUALITY CONTROL) RESULTS WERE LOW BUT RECOVERED JUST WITHIN THE LAB'S ESTABLISHED RANGES. ERRONEOUSLY LOW NA AND CL RESULTS WERE REPORTED OUT OF THE LAB. AFTER THE PROBLEMS WITH THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WERE RESOLVED, THE SAMPLES WERE REPEATED AND AMENDED REPORTS WERE ISSUED FOR APPROX 100 SAMPLES. THE INITIAL NA RESULTS RANGED FROM 130-132 MMOL/L AND THE INITIAL CL RESULTS WERE ABOUT 2-3 MMOL/L LOWER THAN THE REFERENCE RANGE. BOTH THE NA AND CL RESULTS FELL WITHIN THEIR RESPECTIVE REFERENCE RANGES UPON REPEAT. THE CUSTOMER DID NOT PROVIDE ANY PT RESULTS OR SAMPLE INFO. WHILE THE CUSTOMER DID NOT RECEIVE ANY REPORT OF ANY ADVERSE EVENT OR PT INJURY ASSOCIATED WITH THIS EVENT, THERE WERE CHANGES TO PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK