BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREPMATE ACCESSORY

    MDR report key: 1593771 · Received July 8, 2009

    Report

    Report Number
    1062336-2009-00001
    Event Type
    Malfunction
    Date Received
    July 8, 2009
    Date of Event
    April 20, 2009
    Report Date
    July 8, 2009
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 (B)(6)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. AN MDR (1032336-2007-00003) WAS SUBMITTED IN 10/2007 DESCRIBING THE EVENTS AND ACTIONS. TECHNICAL BULLETIN TO ALL CUSTOMERS REINFORCING PROPER CLEANING METHODS. ADDITION OF WARNING TO OPERATOR'S MANUAL; ADDITION OF POLYCARBONATE SHIELD INSIDE THE INSTRUMENT TO FURTHER PROTECT THE HORIZONTAL INTERFACE BOARD FROM EXPOSURE TO LIQUID. THESE CHANGES WERE INCLUDED IN A PMA SUPPLEMENT (B)(4) WHICH WAS APPROVED ON 11/07/2008. THE INSTRUMENT INVOLVED IN THIS INCIDENT WAS ORIGINALLY MANUFACTURED IN 01/2006 AND HAD NEVER BEEN REFURBISHED. THE UNIT WAS NOT FITTED WITH THE POLYCARBONATE SHIELD BECAUSE IT WAS IN STORAGE FOR SEVERAL YEARS AT THE CUSTOMER SITE AND COULD NOT BE LOCATED FOR UPGRADE. THE INSTRUMENT WAS RETURNED TO TRIPATH IMAGING FOR EVALUATION. IT WAS CONFIRMED THAT AN ELECTRICAL SHORT CIRCUIT ON THE HORIZONTAL INTERFACE BOARD WAS THE ROOT CAUSE OF THE EVENT. THERE WAS ALSO EVIDENCE OF CORROSIVE CLEANING SOLUTION IN THE BOTTOM OF THE UNIT. THIS INDICATES THAT THE CUSTOMER WAS LIKELY NOT FOLLOWING INSTRUCTIONS FOR CLEANING THE INSTRUMENT WITH A DAMP CLOTH AND MILD CLEANSER AND MAY HAVE DAMAGED THE HORIZONTAL INTERFACE BOARD.

    Description of Event or Problem · 1

    A LABORATORY TECH NOTICED A BURNING RUBBER SMELL JUST BEFORE THE PREPMATE INSTRUMENT STOPPED OPERATING. THERE WAS NO DAMAGE TO THE LABORATORY OR PERSONNEL. NO PT 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1