BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3211845 · Received July 8, 2013

    Report

    Report Number
    2050012-2013-00468
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) WAS WITHIN LABORATORY SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. PATIENT SAMPLES ARE COLLECTED IN 4 ML SARSTEDT TUBES, ANALYZED FRESH, AND STORED AT ROOM TEMPERATURE. THE SAMPLES ARE CENTRIFUGED FOR 10 MINUTES AT 3000 RPM. THE CUSTOMER DISCOVERED THE TUBING FROM THE TOP OF THE LEVEL SENSE BEAD WAS LOOSE. THE CUSTOMER TIGHTENED THE CONNECTION WHICH RESOLVED THE ISSUE. THE CUSTOMER HAS NOT REPORTED A REOCCURRENCE OF THE ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT SINCE THE CUSTOMER CORRECTED THE ISSUE. THE CURRENT FAILURE MODE IS HARDWARE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK IN THE CARTRIDGE CHEMISTRY (CC) REAGENT PROBE A IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER ALSO INDICATED THAT THE INSTRUMENT PRODUCED ERRATIC VANCOMYCIN (VANC) FOR ONE (1) PATIENT SAMPLE AND GENTAMICIN (GEN) PATIENT RESULTS FOR THREE (3) PATIENT SAMPLES. THE SAMPLES WERE RE-ANALYZED ON AN ALTERNATE INSTRUMENT. THE INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, THERE WAS NO DEATH, AFFECT TO PATIENT TREATMENT, OR SERIOUS INJURY REQUIRING MEDICAL ATTENTION ASSOCIATED WITH THE ERRONEOUS RESULTS AND LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308575 UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1