BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 1941258 · Received December 29, 2010

    Report

    Report Number
    1061932-2010-00316
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOW VACCUM SUPPLIED TO THE PROBE WIPE ASSEMBLY DURING THE RINSE CYCLE ALLOWED DILUENT TO ACCUMULATE AROUND PROBE RINSE BLOCK. THE EXCESS DILUENT DRIPPED ONTO THE TOP OF THE TUBE. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED SOME HARDWARE PARTS. THE CUSTOMER VERIFIED CONTROLS. THE ROOT CAUSE FOR THE LEAK MAY BE ASSOCIATED WITH LOW VACUUM SUPPLIED TO THE PROBE WIPE ASSEMBLY DURING THE PROBE RINSE CYCLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT AFTER PROBE ASPIRATION ON THE COULTER ACT DIFF 2 ANALYZER, THE SAMPLE VIALS HAD BLOOD LEFT ON THE RUBBER CAP. THE REPORTED EVENT ONLY OCCURRED ON THE LAST TWO SAMPLES RAN AND NO OTHER SAMPLE VIALS OR CONTROL VIALS HAD SAME OUTCOME. THE CUSTOMER VERIFIED WEARING PROPER PPE DURING THIS EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1