BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3160751 · Received June 10, 2013

    Report

    Report Number
    2050012-2013-00403
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) ON THE DAY OF THE EVENT HAD BEEN EXHIBITING SOME IMPRECISION, WITH HIGH OUT OF RANGE RECOVERY PRIOR TO THE EVENT. THE SYSTEM WAS RECALIBRATED AND QC RECOVERED NEAR THE MEAN, AT WHICH THE TIME THE SAMPLES WERE RUN. NO SAMPLE COLLECTION OR METHOD OF ANALYSIS WAS PROVIDED BY THE CUSTOMER. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE DISASSEMBLED AND CLEANED THE FLOWCELL. THE FSE OBSERVED BUILD UP BY BOTH THE NA AND CL PORTS. THE FSE REPLACED THE NA REFERENCE ELECTRODE, CL ELECTRODE TIP AND BOTH CO2 ELECTRODES. THE FSE ALSO REPLACED THE CARBON BRIDGE. THE FSE ALSO REPLACED THE RATIO PUMP AS A PREVENTIVE MAINTENANCE SINCE IT WAS DUE TO BE REPLACED IN TWO WEEKS. FAILURE MODE IS UNKNOWN. MULTIPLE PARTS WERE REPLACED AND ACTIONS TAKEN, ANY OF WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MDR 2050012-2013-00402 IS ASSOCIATED WITH THIS EVENT AND DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2013.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FALSE HIGH SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), AND/OR CARBON DIOXIDE (CO2) RESULTS FOR THREE (3) PATIENT SAMPLES ON TWO (2) DIFFERENT DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE PATIENT RESULTS GENERATED ON (B)(6) 2013 FOR ONE (1) OF THE THREE PATIENT SAMPLES THAT WERE AFFECTED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND YIELDED RESULTS WITHIN THE NORMAL RANGE AND THOSE RESULTS WERE AMENDED. THE CUSTOMER HAS CONFIRMED THAT THERE HAS BEEN NO EFFECT TO PATIENTS OR CHANGE IN PATIENT TREATMENT IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260093 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR