BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2213760 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-04471
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER REPLACED THE SAMPLE PROBE AND COLLAR WASH. ALTHOUGH REPAIRS WERE MADE TO THE INSTRUMENT BEFORE RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUSLY LOW MODULAR BLOOD UREA NITROGEN (BUNM) RESULT WAS GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS NOT RELEASED FROM THE LABORATORY AND HENCE THERE HAS BEEN NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. UPON MULTIPLE REPEATS OF THE SAME SAMPLE ON THE SAME INSTRUMENT, THE BUNM RESULTS WERE HIGHER, AND CONSIDERED VALID. THE BUNM SAMPLE WAS A SERUM SAMPLE. NO ADDITIONAL SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. INSTRUMENT BUNM QUALITY CONTROL RESULTS DURING THE TIMEFRAME OF THE EVENT WERE WITHIN CUSTOMER SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR