BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2260887 · Received September 23, 2011

    Report

    Report Number
    2050012-2011-05585
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. 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 A SUPPRESSED TRANSFERRIN PATIENT RESULT WITH AN INSTRUMENT FLAG WAS GENERATED ON AN UNICEL DXC 600 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. THE INSTRUMENT FLAG ASSOCIATED WITH THE SUPPRESSED RESULTS WAS AN OIR LO FLAG WHICH INDICATES THAT THE RESULT IS OUT OF INSTRUMENT RANGE LOW. THE CHEMISTRY'S CUSTOMER INFORMATION SHEET DOES NOT STATE NOT TO REPORT OIR LO RESULTS; HOWEVER THE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO OTHER PATIENT RESULTS OR CHEMISTRIES WERE AFFECTED. PATIENT INFORMATION AND SAMPLE HANDLING/COLLECTION INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. INSTRUMENT CHEMISTRY QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS AT THE TIMEFRAME OF THE EVENT. NO OTHER INSTRUMENT ERRORS WERE NOTED IN THE INSTRUMENT'S EVENT LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1