BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2131788 · Received June 16, 2011

    Report

    Report Number
    2050012-2011-02390
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE GENERATION OF ERRONEOUS RESULTS, THE CUSTOMER ATTEMPTED TO REBOOT THE INSTRUMENT. THE INSTRUMENT WOULD NOT RETURN TO NORMAL PRODUCTION STATE. A FIELD SERVICE ENGINEER WAS DISPATCHED. THE INSTRUMENT SOFTWARE WAS UPGRADED. ALTHOUGH MODIFICATIONS WERE MADE TO THE INSTRUMENT PRIOR TO RETURNING IT INTO SERVICE, A DEFINITE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED TO DATE. - ATTACHMENT: [PATIENT RESULTS(MDR#2050012-2011-02390).PDF]

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON 06/04/2011 AN ERRONEOUSLY LOW TOTAL PROTEIN (TP) RESULT WAS GENERATED ON A UNICEL DXC 600 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. A REPEAT TEST ON THE SAME INSTRUMENT CORROBORATED THE INITIAL, ERRONEOUS TEST RESULT. THE REPEAT TEST RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SUBSEQUENT RETESTS OF THE SAME SAMPLE ON THE SAME INSTRUMENT, AS WELL AS A DIFFERENT INSTRUMENT, GENERATED HIGHER RESULTS THAT WERE CONSIDERED VALID. A CORRECTED REPORT WAS ISSUED. 5. QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER'S ESTABLISHED RANGES BEFORE THIS EVENT. 6. THE CUSTOMER DID NOT PROVIDE ANY SAMPLE PREPARATION OR HANDLING INFORMATION.

    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 52 YR