BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 1916732 · Received December 7, 2010

    Report

    Report Number
    1061932-2010-00252
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND RECOVERED WITHIN ASSAY RANGE. PER CUSTOMER THE CONTROL RECOVERED LOW AFTER PATIENT RESULTS RECOVERED LOW. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED SWEEP FLOW CANISTER, PROVE AND ISOLATION CHAMBER. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT. CHANGE FROM K955016 TO K990352.

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND RECOVERED WITHIN ASSAY RANGE. PER CUSTOMER THE CONTROL RECOVERED LOW AFTER PATIENT RESULTS RECOVERED LOW. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED SWEEP FLOW CANISTER, PROVE AND ISOLATION CHAMBER. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW PLATELET RESULTS ON MULTIPLE PATIENT SPECIMENS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. INSTRUMENT PRINTOUT WERE NOT PROVIDED; HENCE IT IS UNKNOWN IF THE INSTRUMENT GENERATED ANY FLAGS. NO MANUAL PLATELET COUNTS WERE PERFORMED. NO CHANGE TO PATIENT TREATMENT AND NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW PLATELET RESULTS ON MULTIPLE PATIENT SPECIMENS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. INSTRUMENT PRINTOUT WERE NOT PROVIDED; HENCE IT IS UNKNOWN IF THE INSTRUMENT GENERATED ANY FLAGS. NO MANUAL PLATELET COUNTS WERE PERFORMED. NO CHANGE TO PATIENT TREATMENT AND NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1