BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2213701 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-03779
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT WAS ASSESSED BY CUSTOMER. IT WAS DETERMINED THAT THE STIRRER MOTOR NEEDED TO BE REPLACED. UPON COMPLETION OF NECESSARY REPAIRS THE INSTRUMENT WAS RETURNED INTO SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS, LOW PHOSPHORUS (PHOSM) RESULTS WERE GENERATED ON A UNICEL DXC 800 SYNCHRON SYSTEM FOR TWELVE PATIENT SAMPLES. THE ERRONEOUS PHOSM RESULTS WERE REPORTED OUT OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE INSTRUMENT PHOSPHORUS QUALITY CONTROL (QC) RESULTS DID NOT RECOVER WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS THE DAY PRIOR TO THE EVENT. ADDITIONALLY, INSTRUMENT RECALIBRATION RESULTS FAILED TO MEET ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT. THE CUSTOMER NOTICED THAT THE STIRRER MOTOR WAS NOT SPINNING. THE STIRRER MOTOR WAS REPLACED. UPON THE COMPLETION OF REPAIRS, THE INSTRUMENT WAS RECALIBRATED SUCCESSFULLY AND RETURNED INTO SERVICE DATA PROVIDED BY THE CUSTOMER INDICATES THAT UPON REPEAT TESTING, THE RESULTS WERE HIGHER AND REGARDED AS VALID. SIX AMENDED REPORTS WERE ISSUED. PATIENT INFORMATION AND SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1