BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREPMATE ACCESSORY

    MDR report key: 1182655 · Received September 25, 2008

    Report

    Report Number
    1062336-2008-00008
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 25, 2008
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TRIPATH IMAGING IDENTIFIED AN INCREASING TREND IN SMOKE/SPARKING EVENTS IN THE PREPMATE INSTRUMENT IN 2007 AND INITIATED AN INVESTIGATION. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR LEADING TO OVER-EXPOSURE OF THE HORIZONTAL INTERFACE BOARD TO CLEANING LIQUIDS. A MDR (1032336-2007-00003) WAS SUBMITTED IN OCTOBER 2007, DESCRIBING THE EVENTS AND ACTIONS. CORRECTIVE ACTIONS INCLUDED: TECHNICAL BULLETIN TO ALL CUSTOMERS REINFORCING PROPER CLEANING METHODS. ADDITION OF WARNING TO OPERATOR'S MANUAL. ADDITION OF SHIELD INSIDE THE INSTRUMENT TO FURTHER PROTECT THE HORIZONTAL INTERFACE BOARD FROM EXPOSURE TO LIQUID THE INSTRUMENT INVOLVED IN THIS INCIDENT WAS ORIGINALLY MANUFACTURED IN DECEMBER 2001 AND WAS LAST REFURBISHED IN AUGUST 2006. IT HAD BEEN SERVICED IN JULY 2008 TO HAVE THE PLASTIC HORIZONTAL INTERFACE BOARD SHIELD. THE INSTRUMENT WAS RETURNED TO TRIPATH IMAGING FOR EVALUATION. IT WAS CONFIRMED THAT ELECTRICAL SHORT CIRCUITING OF THE HORIZONTAL INTERFACE BOARD WAS THE ROOT CAUSE OF THE EVENT. THERE WAS ALSO EVIDENCE OF CLEANING SOLUTION IN THE BOTTOM OF THE UNIT. THIS INDICATES THAT THE CUSTOMER WAS PROBABLY NOT FOLLOWING INSTRUCTIONS FOR CLEANING THE INSTRUMENT WITH A DAMP CLOTH AND LIKELY CAUSING DAMAGE TO THE HORIZONTAL INTERFACE BOARD PRIOR TO INSTALLATION OF THE SHIELD.

    Description of Event or Problem · 1

    A LABORATORY TECHNICIAN NOTICED SMOKE COMING OUT OF THE PREPMATE INSTRUMENT. TECHNICIAN ALSO INDICATED THAT THERE WAS A BAD SMELL. THERE WAS NO DAMAGE TO THE LABORATORY OR PERSONNEL. NO PATIENT SAMPLES WERE LOST OR COMPROMISED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPMATE ACCESSORY CERVICAL CYTOLOGY VIAL PROCESSOR MKQ TRIPATH IMAGING, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1