BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3241781 · Received July 22, 2013

    Report

    Report Number
    9612296-2013-00096
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT PROVIDED. QUALITY CONTROL (QC) WAS RUN PRIOR TO AND AFTER THE EVENT AND WAS OUT OF THE LABORATORY SPECIFIED RANGES. 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 IONIZED SELECTIVE ELECTRODE (ISE) SYSTEM AND RESOLVED THE ISSUE BY REPLACING THE ELECTRODE WIRE CABLES / LEADS. THE FSE REVIEWED THE CALIBRATION SLOPE VALUES AND NOTED BETTER RECOVERY AND STABILITY. THE CUSTOMER VERIFIED ISE CALIBRATION RESULTS WERE IMPROVED. SYSTEM PERFORMANCE WAS VERIFIED TO MEET PUBLISHED SPECIFICATIONS. THE CUSTOMER ALSO VERIFIED ALL QC LEVELS WERE WITHIN INTERNAL FACILITY SPECIFICATIONS BEFORE RUNNING PATIENT SAMPLES. THE CUSTOMER CONFIRMED THAT THEY HAVE HAD NO FURTHER ISE ISSUES WITH CALIBRATION DRIFT OR LOW ISE VALUES. THE FAILURE MODE IS RELATED TO HARDWARE, ISE ELECTRODE LEADS. MDR 9612296-2013-00095 IS RELATED TO THIS EVENT WHICH DOCUMENTS THE ERRONEOUSLY LOW NA PATIENT RESULTS OBTAINED ON (B)(6) 2013.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING ERRONEOUSLY LOW SODIUM (NA) PATIENT RESULTS GENERATED ON THE (B)(4) CLINICAL CHEMISTRY ANALYZER ON TWO DIFFERENT DAYS (B)(6) 2013. THIS REPORT DOCUMENTS THE THREE (3) ERRONEOUSLY LOW NA PATIENT RESULTS OBTAINED ON (B)(6) 2013. THE CUSTOMER ALSO REPORTED ONGOING CALIBRATION AND QUALITY CONTROL (QC) INSTABILITY AND DRIFT ISSUES ON THE ANALYZER. 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
    340457 OLYMPUS AU481-02E CLINICAL CHEMISTRY ANALYZER (WITH ISE) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU481-02E (WITH ISE) NA

    Patients

    Seq Age Sex Outcome Treatment
    1