BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2356932 · Received December 4, 2011

    Report

    Report Number
    2050012-2011-08062
    Event Type
    Malfunction
    Date Received
    December 4, 2011
    Date of Event
    October 24, 2011
    Report Date
    October 24, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    CKB
    PMA / PMN Number
    K981743
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS INITIALLY SUBMITTED ON (B)(6) 2011 WITHIN THE 30 DAY DEADLINE; HOWEVER, INADVERTENTLY THE YEAR WAS ENTERED AS 2010 ON THE REPORT NUMBER INSTEAD OF 2011. WAS 2050012-2010-08062. SHOULD HAVE BEEN 2050012-2011-08062.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO AN ERRONEOUS SODIUM (NA) RESULT ON A FEMALE, WHICH WAS GENERATED BY THE AU400. THE ERRONEOUS RESULT WAS REPORTED OUT LABORATORY; HOWEVER, PATIENT TREATMENT WAS NOT IMPACTED BY THE EVEN. THE SAMPLE WAS REPEATED HIGHER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED AND THE RESULT AMENDED. THE SAMPLE WAS HEPARINIZED PLASMA. PER CUSTOMER: ISE CALIBRATION DATA LOOKS ACCEPTABLE. QC IN RANGE BEFORE AND AFTER EVENT. ANALYZER MAINTENANCE IS CURRENT. ON THE DAY OF THE EVENT, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. PER FSE , THE UNIT HAS BEEN GIVING OCCASIONAL LOW ISE RESULTS. THE FSE NOTED THE D-POT NOT DRAINING PROPERLY FOLLOWING WEEKLY MAINTENANCE PERFORMED ON (B)(4) 2011, WHEN THE ERRORS STARTED. THE FSE REPLACED THE D-POT TO THE DRAIN, THE ISE STARTED DRAINING PROPERLY. CALIBRATED TWO TIMES AND RAN QC TWO TIMES, QC GOOD. VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE: CLOGGED ISE TUBING AND CLOGGED WASTE TUBING CAUSING SAMPLE POT TO NOT EMPTY PROPERLY BETWEEN SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER ACID PHOSPHATASE, NAPHTHYL PHOSPHATE CKB BECKMAN COULTER MISHIMA K.K. AU400-ISE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR