BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2924785 · Received January 22, 2013

    Report

    Report Number
    1061932-2013-00096
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC COULTER ACT DIFF 2 ANALYZER REFERENCE MANUAL STATES IN PERTINENT PARTS AS FOLLOWS: "(B)(4). "

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE COULTER ACT DIFF 2 ANALYZER, (SYSTEM ID (B)(4)) GENERATED PLATELET (PLT) RESULTS THAT DID NOT MATCH THE OTHER COULTER ACT DIFF 2 ANALYZER (SYSTEM ID (B)(4)), IN THE LABORATORY. CUSTOMER REPORTED THE SAMPLES WERE DRAWN FROM CANCER PATIENTS WITH LOW PLATELET COUNTS THAT REGULARLY RECEIVE CANCER THERAPY. THE CUSTOMER DID NOT CONSIDER THE RESULTS FROM EITHER ANALYZER TO BE ERRONEOUS AS THE RESULTS WERE ABOVE THEIR TREATMENT PROTOCOL. CUSTOMER INDICATED THERE WAS NO IMPACT TO PATIENT TREATMENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED CONTROLS RUN ON THE INSTRUMENT WERE PERFORMING WITHIN SPECIFICATIONS. THE FSE VERIFIED LATEX (APERTURE GAIN) AND LOW VACUUM SETTINGS WERE WITHIN SPECIFICATIONS. ON A FOLLOW-UP CALL WITH THE CUSTOMER, CUSTOMER INDICATED THEY DID NOT HAVE ANY FURTHER ISSUES WITH PLATELET CORRELATION.

    Description of Event or Problem · 1

    PER CUSTOMER, RADIATION TREATMENT FOR PATIENT #1 (A) WAS WITHELD ON (B)(6) 2012 BECAUSE CUSTOMER DID NOT TRUST RESULTS GENERATED BY THE COULTER ACT* DIFF 2 ANALYZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29321 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other