BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 3191482 · Received June 26, 2013

    Report

    Report Number
    1061932-2013-01193
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE REPLACED WORN AND DIRTY VIC (VACUUM ISOLATION CHAMBER), REPLACED ALL 3 SYRINGES AND VALVES LV10, LV11, LV12. THE FSE ALSO FLUSHED VACUUM LINES AND REPLACED VACUUM ISOLATION FILTER (GREEN FLUID BARRIER FILTER). THE FSE CHECKED HEMOGLOBIN (HGB) VOLTAGE, VACUUM AND RAN A STARTUP, REPRODUCIBILITY AND CONTROLS; ALL RESULTS WERE WITHIN SPECIFICATION AND NO FURTHER CONTROL ISSUE OR LEAK WERE OBSERVED. FAILURE MODE CAN BE ATTRIBUTED TO THE NUMEROUS PARTS REPLACED BY THE FSE (VIC, SYRINGES, AND VALVES 10, 11, AND 12). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEY WERE RUNNING QUALITY CONTROL (QC) ON THEIR COULTER ACT-DIFF ANALYZER AND THEY DISCOVERED THAT THE PROBE LEAKED/DRIPPED AND THEY WERE HAVING AN ONGOING CONTROL RECOVERY ISSUE FOR THE HEMOGLOBIN (HGB) PARAMETER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. PER THE CUSTOMER, THEY WERE WEARING GLOVES AND LABORATORY COATS AT THE TIME OF THIS EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. CUSTOMER CONFIRMED PATIENT RESULTS/TREATMENT WERE NOT AFFECTED IN RELATION TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291309 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1