BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP MEGA SAMPLE PROCESSOR

    MDR report key: 734417 · Received June 30, 2006

    Report

    Report Number
    3003402518-2006-00001
    Event Type
    Other
    Date Received
    June 30, 2006
    Date of Event
    May 1, 2006
    Report Date
    June 30, 2006
    Manufacturer
    TECAN AG
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD ENGINEER WAS DISPATCHED TO THE SITE TO INVESTIGATE THE ISSUE ON 05/18/2006 AND REPLACED THE APPROPRIATE COMPONENTS ON THE DEVICE AND PERFORMED DIAGNOSTIC TESTING WITHIN SPECIFIC VERIFIED TIP POSITIONS. THE INSTRUMENT WAS RETURNED TO WORKING ORDER WITHIN MFR SPECIFICATINS. NO DEFINITIVE CAUSE FOR THE PRESENCE OF FLUID COULD BE FOUND FOR THE DROPLETS ON THE CARDS. PRODUCT LABELING OF THE DEVICE REQUIRE THE USER TO VISUALLY MONITOR THE FIRST RUN OF THE DAY FOR PIPETTING AND ALIGNMENT ISSUES. OPERATORS MUST ALSO VISUALLY REVIEW TESTS PREPARED ON THE TECAN FOR INTERPRETATION OF RESULTS. ERRONEOUS RESULTS WERE NOT REPORTED AS A RESULT OF THIS INCIDENT. THE USER VISUALLY REVIEWED AND ACCEPTED EACH TEST PROCESSED ON THE INSTRUMENT. CARRY OVER AND CROSS CONTAMINATION WAS NOT REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AN ALIGNMENT ISSUE WITH THE PIPETTING APPARATUS ON THE TECAN MEGAFLEX ID LED TO FLUID ON TOP OF THE MTS GEL CARDS. FLUID ON TOP OF THE MTS GEL CARDS, DUE TO AN INCIDENT DURING PIPETTING OF SAMPLE OR REAGENT, MAY LEAD TO CARRY OVER, CROSS CONTAMINATIN, OR MEAKENED REACTIVITY AS A RESULT OF DILUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP MEGA SAMPLE PROCESSOR PIPETTING AND DILUTING SYSTEM FOR CLINICAL U JQW TECAN AG MTS9950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other