BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT DIFF

    MDR report key: 2060428 · Received April 16, 2011

    Report

    Report Number
    1061932-2011-00260
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED FOR THIS EVENT. QC WAS RUN BEFORE AND AFTER THE INCIDENT AND WERE WITHIN QC SPECIFICATION. BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT BUT DID NOT FIND ANY INSTRUMENT RELATED PROBLEMS. QC WAS CHECKED AND THE INSTRUMENT WAS VERIFIED. AT THIS TIME, ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE ACT DIFF INSTRUMENT GENERATED INCORRECT LOW WBC, HGB & HIGH MCV RESULTS FOR ONE (1) PATIENT SPECIMEN WHEN COMPARED TO REFERENCE INSTRUMENT RESULTS. THE SAMPLE PRINTOUT FOR THE ACT DIFF INSTRUMENT CAME FROM AN LIS AND DOES NOT REFLECT INSTRUMENT GENERATED FLAGS, MESSAGES OR HISTOGRAMS. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. PATIENT WAS SENT TO THE HOSPITAL FOR OTHER ADDITIONAL SCHEDULED TESTS. ANOTHER SAMPLE WAS REDRAWN AND RUN ON A REFERENCE INSTRUMENT. SAMPLE RESULTS WERE HIGHER FOR WBC, RBC, HGB AND LOWER FOR MCV AND PLT RESULTS. NO ADDITIONAL SAMPLES WERE IMPACTED BY THIS EVENT. THERE WAS NO DEATH OR INJURY AS A RESULT OF THIS INCIDENT;.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT DIFF DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization