BEUDAMED
    FDA Adverse Event Other Summary report: N

    MTS PIPETTE

    MDR report key: 899185 · Received August 19, 2007

    Report

    Report Number
    9681721-2007-00014
    Event Type
    Other
    Date Received
    August 19, 2007
    Date of Event
    June 21, 2007
    Report Date
    August 18, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE HERE A CUSTOMER RESPONDING CORRECTLY AND QUICKLY TO PREVENT FALSE READINGS AND INCORRECT TEST RESULTS. THE COMPLAINT WAS NEVER ACTUALLY CONFIRMED IN THIS INSTANCE BUT THE PIPETTE WAS REPLACED AND NOT INTENDED FOR FURTHER USE AS IS. IT IS THE EXPERIENCE OF THE MFR THAT THIS TYPE OF PROBLEM IS NOT ONLY CORRECTABLE ALLOWING THE PIPETTE TO AGAIN BE REUSED AFTER CORRECTIVE SERVICE, BUT IN MOST INSTANCES PREVENTABLE SHOULD THE CUSTOMER FOLLOW RECOMMENDED MFR GUIDELINES FOR PREVENTATIVE SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BIOHIT PIPETTOR WAS DRIPPING FLUID AFTER ASPIRATION. THE CUSTOMER CLEANED THE PIPETTOR FOR TWO DAYS AND USED THE PIPETTOR WITHOUT ANY DRIPS. HOWEVER, THE PIPETTOR STARTED DRIPPING AGAIN. THE CUSTOMER IMMEDIATELY DISCONTINUED USING THE PIPETTOR AND RETESTED THE SAMPLES USING A DIFFERENT PIPETTOR. THE CUSTOMER WAS UNABLE TO PROVIDE ADD'L INFO REGARDING THIS ISSUE. THE CUSTOMER INDICATED THAT THE PIPETTOR WAS RECENTLY RECEIVED IN 2007 AND HAD PREVIOUSLY REPORTED FOR VOLUME VERIFICATION FAILURE. THE CUSTOMER'S ISSUE WAS RESOLVED BY PRODUCT REPLACEMENT. THE CUSTOMER WAS INSTRUCTED BY CTS TO SEND THE PIPETTOR TO THE REPAIR DEPOT. SERVICE ORDER ENTRY IS STILL PENDING. THE CUSTOMER REPORTED THAT THERE WERE NO ERRONEOUS RESULTS REPORTED. A SEARCH WAS PERFORMED CONCERNING COMPLAINTS LOGGED BY THIS CUSTOMER. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT, INDICATING THAT THE PIPETTOR IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS PIPETTE ELECTRONIC PIPETTOR JTC BIOHIT OYJ 710142MT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR