BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU481-02E CLINICAL CHEMISTRY ANALYZER (WITH ISE)

    MDR report key: 3203184 · Received July 2, 2013

    Report

    Report Number
    9612296-2013-00085
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CEM
    PMA / PMN Number
    K981743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT PROVIDED. THE CUSTOMER INDICATED THAT THE K QUALITY CONTROL (QC) RECOVERED HIGH. THE OPERATOR PERFORMED AN IONIZED SELECTIVE ELECTRODE (ISE) CLEANING AND RECALIBRATED, BUT QC REMAINED HIGH. THE CUSTOMER DID NOT PROVIDE ANY DOCUMENTATION OF CALIBRATION OR QC DATA. SERVICE WAS REQUESTED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE EVALUATED THE ISE AND DETERMINED THAT THE ISE REFERENCE VALVE WAS FAULTY AS THERE WERE VISIBLE AIR BUBBLES IN THE LINES DURING PRIMING. THE REFERENCE VALVE WAS REPLACED AND THE ISE SYSTEM WAS RETURNED TO OPERATIONAL. SYSTEM PERFORMANCE WAS RETURNED TO SPECIFICATIONS. SYSTEM VALIDATION WAS DOCUMENTED IN CUSTOMER QC RECORDS. THERE HAVE BEEN NO FURTHER ISSUES NOTED WITH K RECOVERY. FAILURE MODE: FAILED ISE REFERENCE VALVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING FALSE HIGH POTASSIUM (K) RESULTS FOR APPROXIMATELY FIFTY (50) PATIENT SAMPLES GENERATED ON THE AU481-02E CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT THE FALSE K RESULT VALUES WERE OVER 100 MMOL/L AND UPON REPEAT ON AN ALTERNATE AU INSTRUMENT GENERATED RESULTS WITHIN NORMAL RANGE. NORMAL REFERENCE RANGE FOR K IS 3.5 - 5.1 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT PROVIDE SPECIFIC PATIENT DEMOGRAPHICS OR DATA DOCUMENTATION. THERE WAS NO AFFECT TO PATIENT OR PATIENT TREATMENT IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302095 OLYMPUS AU481-02E CLINICAL CHEMISTRY ANALYZER (WITH ISE) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CEM BECKMAN COULTER AU481-02E (WITH ISE) NA

    Patients

    Seq Age Sex Outcome Treatment
    1