BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4C PLUS COULTER CELL CONTROL

    MDR report key: 2171360 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00772
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K955016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER TWO CONTROL LEVELS WITHIN THE KIT DID NOT EXHIBIT THIS ISSUE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND THEREFORE NOT AVAILABLE FOR EVAL. THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR LEAKING VIALS UPON RECEIPT FOR 4C PLUS COULTER CELL CONTROL WITHIN THE PAST 12 MONTHS. ROOT CAUSE IS UNK. 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 BIOHAZARD WHEN USING THE 4C PLUS COULTER CELL CONTROL. CUSTOMER REPORTED THAT UPON RECEIPT, THE ABNORMAL HIGH VIAL HAD LEAKED DUE TO A LOOSE CAP. OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO EFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4C PLUS COULTER CELL CONTROL JPK BECKMAN COULTER, INC. NA 1000112K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER AC-T DIFF 2 ANALYZER