BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT¿ 5DIFF AUTOLOADER (AL)

    MDR report key: 2990816 · Received March 5, 2013

    Report

    Report Number
    1061932-2013-00363
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE SYRINGE ASSEMBLY FOR THE HEMOGLOBIN LYSE WAS CRACKED. THE CRACK CAUSED A VACUUM WHICH PULLED THE HEMOGLOBIN LYSE FLUID FROM THE BOTTLE AND THROUGH THE SYRINGE ASSEMBLY. THE FSE REPLACED THE SYRINGE ASSEMBLY FOR THE HEMOGLOBIN LYSE AND RESOLVED THE ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY ONE HALF OF THE REAGENT BOTTLE'S FLUID LEAKED OUTSIDE FROM THE LEFT SIDE OF THE INSTRUMENT, FROM THE SYRINGE, INVOLVING THE COULTER ACT 5DIFF AUTOLOADER (AL). THE OPERATOR WAS WEARING GLOVES AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE LABORATORY HAS AN EXPOSURE CONTROL PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93590 COULTER® ACT¿ 5DIFF AUTOLOADER (AL) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1