BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2700 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1751505 · Received July 10, 2010

    Report

    Report Number
    2050012-2010-00390
    Event Type
    Malfunction
    Date Received
    July 10, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K003721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRATION AND QC WAS WITHIN SPECIFICATIONS BEFORE THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE VERIFIED THE INSTRUMENT AND FOUND NO ABNORMALITIES. NO ROOT CAUSE HAS BEEN DETERMINED FOR THE INCORRECT RESULT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A FALSE HIGH CREATININE RESULT GENERATED BY THE AU2700 CLINICAL CHEMISTRY ANALYZER FOR ONE PATIENT. THE HIGH RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. THE LAB RE-TESTED THE ORIGINAL SPECIMEN AND OBTAINED A LOWER RESULT. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2700 CLINICAL CHEMISTRY ANALYZER AU2700 CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU2700

    Patients

    Seq Age Sex Outcome Treatment
    1