BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2701-02 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1887081 · Received November 1, 2010

    Report

    Report Number
    2050012-2010-01155
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    JJE
    PMA / PMN Number
    K002982
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND FOUND FOAM IN THE REAGENTS AND SOME OF IT COATED ONE OF THE REAGENT PROBES. THE REAGENTS WERE CLEARED AND THE PROBES WERE SONICATED. THE FSE INSPECTED ALL SYRINGES, PERFORMED CALIBRATION AND QC, CALIBRATION VERIFICATION, AND PRECISION TEST. SYSTEM PERFORMED ACCORDING TO SPECIFICATIONS. THIS EVENT IS DUE TO IMPROPER HANDLING OF THE PHOSPHORUS REAGENT. THE CUSTOMER DISCOVERED ONE OF THE SAMPLE PROBES WERE LEAKING, WHICH WAS CORRECTED BY THE FSE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO PRODUCING AN ERRONEOUS INORGANIC PHOSPHORUS (P) RESULT GENERATED BY THE AU2701-02 CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN WHETHER PATIENT WAS AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2701-02 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMAK.K. AU2701-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1