BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF WBC LYSE

    MDR report key: 2169814 · Received July 15, 2011

    Report

    Report Number
    1061932-2011-00869
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    December 16, 2009
    Report Date
    December 16, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. THE CUSTOMER DISCARDED THE LEAKING REAGENT BOTTLES. THE ROOT CAUSE IS UNK. A REVIEW WAS CONDUCTED. THERE WAS ONLY (B)(4) OTHER SIMILAR REPORT OF REAGENT LEAKING UPON DELIVERY FROM 2004 TO 2009. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL HAZARD WHEN THE ACT 5DIFF WBC LYSE REAGENT WAS LEAKING FROM THE CAP. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. NO CONTACT TO EYES OR SKIN TO THE REAGENT. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT AND GLOVES. MEDICAL ATTENTION WAS NOT REQUIRED FOR THIS EVENT. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT 5DIFF WBC LYSE GGK BECKMAN COULTER, INC. NA 13202B07270

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER ACT 5DIFF CAP PIERCE (CP)