BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER

    MDR report key: 2120924 · Received June 13, 2011

    Report

    Report Number
    1061932-2011-00622
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT WAS SENT TO THE CUSTOMER. THE VIAL WAS RETURNED AND WILL BE FORWARD TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO THE ACT 5DIFF CONTROL PLUS HIGH VIAL WOULD NOT STAY SCREWED ON DUE TO ITS THREADS (LOOSE CAP). NO INDICATION OF SPILL WAS NOTED. THE USER WAS WEARING GLOVES, LAB COAT AND GLASSES WHILE HANDLING THE VIAL AND HAD NO CONTACT WITH THE CONTROL MATERIAL. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER, GKZ BECKMAN COULTER INC. ACT 5DIFF CP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1