BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU681-10E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3243753 · Received July 23, 2013

    Report

    Report Number
    9612296-2013-00097
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR PREPARATION INFORMATION WAS SUPPLIED. THE CUSTOMER PROVIDED CALIBRATION AND QUALITY CONTROL (QC) DATA WHICH DO NOT INDICATE ANY PROBLEMS WITH THE CALIBRATIONS OR QC RECOVERY. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CLEANED ALL CUVETTES, PERFORMED PHOTOCELL, AND REPLACED THE SAMPLE WASH VALVE. THE CUSTOMER INDICATED THAT THERE HAVE NO MORE ERRATIC RECOVERY ISSUES SINCE THE VALVE WAS CHANGED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE OLYMPUS AU681-10E CLINICAL CHEMISTRY ANALYZER GENERATED TWO (2) ERRONEOUSLY HIGH CALCIUM (CA) PATIENT RESULTS. THE SAMPLES WERE RERAN AND YIELDED RESULTS WITHIN NORMAL RANGE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT DEMOGRAPHICS (AGE, DATE OF BIRTH, GENDER, AND WEIGHT) WERE NOT SUPPLIED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342617 OLYMPUS AU681-10E CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU681-10E NA

    Patients

    Seq Age Sex Outcome Treatment
    1