BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 3180777 · Received June 20, 2013

    Report

    Report Number
    1061932-2013-01131
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, THE CUSTOMER WAS ASSISTED OVER THE PHONE BY THE CUSTOMER TECHNICAL SUPPORT (CTS), WHO HELPED THE CUSTOMER CHANGE THE DUAL DILUENT FILTERS AND ADJUST THE HEMOGLOBIN (HGB) LAMP, RESOLVING THE REPORTED PROBLEM. BECKMAN COULTER SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ALTHOUGH THE CAUSE OF THE LEAK CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED, THE REPLACEMENT OF THE DILUENT FILTERS, PERFORMED BY THE CUSTOMER, RESOLVED THE LEAK. THE INSTRUMENT PERFORMED AS EXPECTED RECOVERING HGB INCOMPLETE ON THE START UP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A 1CC REAGENT LEAK FROM THE PROBE OF THE COULTER AC*T-DIFF ANALYZER AFTER A STARTUP. THE THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED RECOVERING HEMOGLOBIN (HGB) INCOMPLETE ON THE STARTUP RESULTS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE LEAK. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO PATIENT SAMPLES WERE AFFECTED BY THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280192 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1