BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2700 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2142042 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02736
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 28, 2011
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    JGS
    PMA / PMN Number
    K003721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE NA QC WAS WITHIN RANGE PRIOR TO THE EVENT. NA QC WAS OUT OF RANGE (LOW) AFTER THE EVENT. CALIBRATION DATA WAS NORMAL PRIOR TO THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THIS EVENT. THE FSE CHANGED THE LOCATION OF THE 'Y' PINCH VALVE TUBING, CHANGED THE URINE CALIBRATORS, CLEANED, PRIMED, AND RAN QC. ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE RETURNED ON (B)(6) 2011 AND DISCOVERED THAT THE 'Y' TUBING WAS NOT ALL THE WAY ON THE PINCH VALVE. THE FSE SWAPPED THE LEGS ON THE 'Y' TUBING AND PUSHED THE LEGS ALL THE WAY ONTO THE PINCH VALVE. THE FSE VERIFIED ALL OPERATIONS, CLEANED, PRIMED, RAN CALIBRATIONS, AND QC. ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUS SODIUM (NA) RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY, GENERATED BY THE AU2700 CLINICAL CHEMISTRY ANALYZER. UPON REPEAT TESTING, A CORRECTED REPORT WAS ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2700 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER MISHIMAK.K. AU2700 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1