BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC·T DIFF ANALYZER

    MDR report key: 4123466 · Received September 26, 2014

    Report

    Report Number
    1061932-2014-02423
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ABLE TO RESOLVE THE LEAK BY CLEANING THE PROBE. THE INSTRUMENT PERFORMED WITHOUT ANY LEAKS. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN 4 CUBIC CENTIMETERS OF DILUENT LEAKED FROM THE PROBE OF THE COULTER AC·T DIFF ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO DEATH, INJURY, OF AFFECT TO USER OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600095 COULTER AC·T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1