BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 5 DIFF ANALYZER (AUTO LOADER)

    MDR report key: 2500544 · Received March 22, 2012

    Report

    Report Number
    1061932-2012-00937
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND WAS UNABLE TO GET THE ORIGINAL POWER SUPPLY TO WORK THE FSE INSTALLED A NEW POWER SUPPLY ON THE UNIT AND THE OLD POWER SUPPLY WAS RETURNED FOR EVALUATION. BASED ON THE SUPPLIED INFORMATION, THE CAUSE OF THE POP, SMOKE, AND SMELL CANNOT BE DETERMINED TO DATE. PER LABELING, ACT 5DIFF AUTOLOADER, INSTRUCTIONS FOR USE, PN624026, BECKMAN COULTER INC URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) REPORTING A "POP" SOUND, FOLLOWED BY A PUFF OF SMOKE AND A BURNING SMELL COMING FROM THE COULTER ACT 5 DIFF ANALYZER (AUTO LOADER) WHICH AUTOMATICALLY POWERED OFF. THE INSTRUMENT WOULD NOT TURN BACK ON. THE CUSTOMER UNPLUGGED THE SYSTEM UNTIL SERVICE WAS ON SITE. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T 5 DIFF ANALYZER (AUTO LOADER) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. AC*T 5 DIFF AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1