BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2211458 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-02432
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 4, 2009
    Report Date
    March 9, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BCI HOTLINE CUSTOMER SVC TECH DISCUSSED SAMPLE QUALITY AND EFFECTS OF BACTERIAL CONTAMINATION WITH THE CUSTOMER. THE CUSTOMER INDICATED THAT THEY PERFORM A WEEKLY MANUAL ISE MAINTENANCE AND THEY CULTURE THE ISE SYS IN 3 LOCATIONS ONCE A MONTH AND THAT THE CULTURES WERE FOUND TO BE NEGATIVE. THE BCI HOTLINE REP SENT THE CUSTOMER THE BI-WEEKLY MAINTENANCE INSTRUCTIONS. A BCI FSE (FIELD SVC ENGINEER) WAS DISPATCHED TO THE SITE AND PERFORMED TROUBLESHOOTING ON THE SYS. THE FSE REPLACED THE CARBON BRIDGE AND WHILE THIS RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE FOR THE EVENT WAS NOT DETERMINED. THIS IS 1 OF 160 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. THIS IS 1 OF 160 MEDWATCH REPORTS RELATED TO THIS EVENT.

    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 SYS INSTRUMENT. HOWEVER, THE POTASSIUM (K) RESULTS WERE WITHIN THE ACCEPTABLE RANGE. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYS WAS CALIBRATED SUCCESSFULLY AND QC (QUALITY CONTROL) RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES. A PHYSICIAN QUESTIONED THE LOW NA RESULTS AND INDICATED THAT 10 PTS WOULD HAVE TO BE TREATED. THE LAB RERAN THE QC CHECK AGAIN AND FOUND THE NA AND CL QC RECOVERED LOW OUTSIDE OF THE ESTABLISHED RANGES. ALL SAMPLES RUN BETWEEN 2 AM AND 10 AM ON THE DAY OF THE EVENT WERE REPEATED ON THE LAB'S SECOND DXC ANALYZER AND THE RESULTS FOR NA AND CL WERE CORRECTED BUT THE K RESULTS WERE NOT CORRECTED. ONE HUNDRED AND SIXTY CORRECTED REPORTS WERE ISSUED OUTSIDE OF THE LAB. THE CUSTOMER PROVIDED 22 EXAMPLES OF PT RESULTS. WHILE THE CUSTOMER DID NOT RECEIVE ANY REPORT OF ANY ADVERSE EVENT OR PT INJURY ASSOCIATED WITH THIS EVENT, IT IS KNOWN THAT THERE WAS CHANGE TO PT TREATMENT IN AT LEAST 10 CASES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK