BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3211846 · Received July 8, 2013

    Report

    Report Number
    2050012-2013-00469
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) DATA WAS PROVIDED FOR (B)(4) 2013. QC WAS BEGINNING TO SHOW IMPRECISION ON (B)(4) 2013. CUSTOMER STATED THE QC WAS ACCEPTABLE AFTER CALIBRATION. PATIENT SAMPLE INFORMATION AND METHOD OF ANALYSIS WAS NOT PROVIDED BY THE CUSTOMER. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON MULTIPLE DAYS TO EVALUATE THE INSTRUMENT AND CORRECT THE ISSUE. ON (B)(4) 2013, THE FSE REPLACED THE SAMPLE PROBE AND SYRINGE. ON (B)(4) 2013, THE CUSTOMER CALLED BACK AND STATED THAT THE ISSUE WAS NOT RESOLVED. THE FSE REVISITED THE CUSTOMER'S LABORATORY AND REPLACED THE CHLORIDE AND NA ELECTRODES. ON THE SAME DAY, THE CUSTOMER CONTACTED BEC AGAIN STATING THAT THE ISSUE WAS STILL NOT RESOLVED. THE FSE RETURNED AGAIN ON (B)(4) 2013 AND WAS UNABLE TO FIND A DEFINITIVE FAILURE MODE. THE FSE PROACTIVELY REPLACED THE FLOWCELL AND CARBON BRIDGE. THE FOLLOWING DAY ((B)(4) 2013), BEC HOTLINE FOLLOWED UP WITH THE CUSTOMER AND THE CUSTOMER REPORTED THAT THE ISSUE WAS STILL NOT RESOLVED. THE FSE RETURNED AND WAS FINALLY ABLE TO REPLICATE THE EVENT. THE HIGH NA OCCURRED ON THE FIRST SAMPLE AFTER A PERIOD OF INACTIVITY. SERVICE REPLACED THE RATIO PUMP WHICH RESOLVED THE ISSUE. AS OF (B)(4) 2013, THERE HAVE BEEN NO FURTHER IONIZED SELECTIVE ELECTRODE (ISE) ISSUES REPORTED BY THE CUSTOMER. FAILURE MODE WAS ASSOCIATED WITH THE RATIO PUMP. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS REPORTED EVENT: 2050012-2013-00470, 2050012-2013-00471, 2050012-2013-00472, 2050012-2013-00473.

    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) RESULTS FOR SEVERAL PATIENT SAMPLES ON MULTIPLE DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE FIVE (5) PATIENT SAMPLES RAN ON (B)(6) 2013. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RERUN AND AMENDED REPORTS WERE ISSUED. IT IS UNKNOWN WHICH INSTRUMENT GENERATED THE RERUN RESULTS. NA IS THE ONLY ANALYTE BEING QUESTIONED FOR THIS EVENT. PATIENT DEMOGRAPHICS WERE NOT PROVIDED BY THE CUSTOMER (AGE, DATE OF BIRTH, GENDER, WEIGHT, ETC.). THERE WAS NO DEATH, AFFECT TO PATIENT TREATMENT, OR SERIOUS INJURY REQUIRING MEDICAL ATTENTION ASSOCIATED WITH THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311662 UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1