BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2703-03E CLINICAL CHEMISTRY ANALYZER.

    MDR report key: 2221141 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04810
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K003721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE FROM FRESH ADULT PATIENT SAMPLES AND ANALYZED FROM THE PRIMARY TUBES WHICH WERE VACUETTE BD 4 ML TUBES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SAMPLE PROBE AND THE ISE SAMPLE D-POT ON THE ISE UNIT AS THE SAMPLE ARM, WHICH WAS PREVIOUSLY REPLACED DUE TO MISALIGNMENT, WAS CAUSING GROVES IN THE SAMPLE D-POT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT AFTER SERVICE WAS PERFORMED FOR A PREVIOUS REPORTABLE EVENT (MDR 2050012-2011-04801) THE (B)(4) CLINICAL CHEMISTRY ANALYZER GENERATED ERRONEOUSLY LOW SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) RESULTS ON TWO (2) PATIENT SAMPLES. THE TWO (2) SAMPLES WERE THEN REPEATED AUTOMATICALLY ON THE SAME INSTRUMENT AND GAVE HIGHER RECOVERIES. THE SAMPLES WERE THEN TRANSFERRED TO ANOTHER INSTRUMENT IN THE LABORATORY AND CONFIRMED THE REPEAT RUN VALUES AND THE RESULTS WERE THEN REPORTED OUT OF THE LABORATORY. NO TREATMENT TO PATIENT WAS GIVEN UNTIL RESULTS WERE RELEASED AFTER RETESTING. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2703-03E CLINICAL CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU2701-03ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1