BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DIFF CAP PIERCE HEMATOLOGY ANALYZER

    MDR report key: 2110131 · Received June 1, 2011

    Report

    Report Number
    1061932-2011-00525
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A BD 4ML TUBE. QC WAS RUN BEFORE AND AFTER THE INCIDENT, AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. ON MAY (B)(4) 2011, BCI FIELD SERVICE ENGINEER (FSE) REPLACED APERTURE O-RINGS, REAGENT SYRINGE BLOCK. O-RINGS WERE REPLACED ON THE DIFF SYRINGE, WASTE SYRINGE, COUNT SYRINGE, AND THE RINSE BLOCK ASSEMBLY. THE FSE COMPLETED PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE PERFORMED EXTENDED CLEANING PROCEDURE, BLEACHED THE DIFF PATHWAY AND DID THE PROBE ALIGNMENT PROCEDURE. THE FSE NOTED THE SAMPLE TUBE MIXER WAS OVER 10 YEARS OLD AND WORN OUT. THE FSE VERIFIED THE REPAIR AND THE SYSTEM WAS VALIDATED. THE ROOT CAUSE FOR THIS EVENT CAN BE ATTRIBUTED TO THE HARDWARE REPLACED DURING SUBSEQUENT INSTRUMENT SERVICE BY THE FSE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW WHITE BLOOD CELL (WBC), PLATELET (PLT), AND ERRONEOUSLY HIGH RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND HEMATOCRIT (HCT) RESULTS GENERATED BY COULTER ACT 5DIFF CAP PIERCE HEMATOLOGY ANALYZER ON ONE PATIENT SAMPLE WITHOUT INSTRUMENT GENERATED FLAGS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON THE FOLLOWING DAY ON A REFERENCE INSTRUMENT PRODUCED RESULTS THAT WERE CONSIDERED CORRECT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1