BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2210139 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01068
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 3, 2010
    Report Date
    March 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR BLEACHED THE ASPIRATE PROBE. THIS DID NOT RESOLVE THE PROBLEM. FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND IDENTIFIED THAT THE PROBE WIPE TUBING WAS BLOCKED. THE PROBLEM WAS RESOLVED BY REPLACING THE PROBE WIPE TUBING. ROOT CAUSE WAS THE BLOCKED PROBE WIPE TUBING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN USING THE COULTER AC-T DIFF 2 ANALYZER. FLUID WAS REMAINING ON THE TOP OF CONTROL AND SAMPLE TUBES WHEN RUNNING IN A CLOSED VIAL WHOLE BLOOD MODE. OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS WITH THE FLUID ON THE TOP OF THE CONTROL AND SAMPLE TUBES. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC-T DIFF 2 ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK