BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5DIFF CAP PIERCE (CP)

    MDR report key: 2180965 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00678
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    October 20, 2009
    Report Date
    October 20, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2009 TO INVESTIGATE THE EVENT: THE FSE REPLACED THE DIFF SYRINGE O-RINGS AND THE DIFF LAMP. THE FSE VERIFIED THE INSTRUMENT OPERATIONS THE HARDWARE AND IT WAS WITHIN SPECIFICATIONS. ALTHOUGH SEVERAL PARTS WERE REPLACED ON THE INSTRUMENT; NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ACT 5 DIFF INSTRUMENT GENERATED ERRONEOUS LOW NEUTROPHIL (NE) RESULTS ON A PT SPECIMEN. INITIAL ERRONEOUS NE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE ANY PRINTOUTS, CONTROL DATA OR PT SPECIMEN INFO. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT 5DIFF CAP PIERCE (CP) GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACT 5 DIFF FIX