BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3972090 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01799
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED THE LEAK FROM DISCONNECTED TUBING AT VALVE VL8. THE FSE RE-CONNECTED THE TUBING RESOLVING THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF 2 ANALYZER. THE LEAK WAS DESCRIBED AS A FEW ML OF FLUID FROM THE PROBE IN THE ANALYZER. THE LEAK WAS NOT CONTAINED AND WAS IDENTIFIED WHILE THE ANALYZER WAS RUNNING QUALITY CONTROL SAMPLES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THE OPERATOR WAS WEARING LAB COAT AND GLOVES WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF BIOHAZARDOUS EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447283 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1