BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3846742 · Received June 4, 2014

    Report

    Report Number
    9612296-2014-00084
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MZV
    PMA / PMN Number
    K011720
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE FOUND A RUSTY GROUNDING POINT AT THE BOTTOM OF THE ION SELECTIVE ELECTRODE (ISE) UNIT. THE FSE STATED THAT BECAUSE ISE UNIT WAS NOT GROUNDED, IT WOULD PICK UP EXTRANEOUS NOISE. THE FSE CLEANED THE GROUNDING POINT AND PERFORMED A PRECISION STUDY. THERE WERE NO FURTHER REPORTS OF ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A POTASSIUM RESULT WITH AN EXCLAMATION POINT FLAG, "!", FOR ONE PATIENT ON AN AU5400 CLINICAL CHEMISTRY ANALYZER. THE FLAG INDICATES THE ANALYZER WAS UNABLE TO CALCULATE CONCENTRATION. THE PATIENT SAMPLE WAS RERUN AND A RESULT WAS OBTAINED WITHOUT FLAGS. THERE WERE NO PATIENT RESULTS RELEASED FROM THE LABORATORY AND THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327570 AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER AU5400-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1