BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3885229 · Received June 19, 2014

    Report

    Report Number
    1061932-2014-01321
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE CUSTOMER WAS ABLE TO RESOLVE THE LEAK BY REPLACING THE RBC (RED BLOOD CELL) FILTERS ON THE INSTRUMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF 2 ANALYZER. ONE OF THE RBC (RED BLOOD CELL) FILTERS ON THE INSTRUMENT WAS LEAKING DILUENT. THE VOLUME OF THE LEAK WAS REPORTED AS LESS THAN 25 ML AND THE LEAK WAS NOT CONTAINED. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES AND LAB COAT WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361513 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1