BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 800085 · Received December 20, 2006

    Report

    Report Number
    9681721-2006-00002
    Event Type
    Malfunction
    Date Received
    December 20, 2006
    Date of Event
    October 18, 2006
    Report Date
    October 20, 2006
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE BIOHIT PIPETTE DID NOT DISPENSE THE CORRECT VOLUME OF LIQUID. NO DEFINITIVE ROOT CAUSE WAS DETERMINED. THE CUSTOMER ACCORDINGLY DISCARDED THE SAMPLES SO THAT NO ERROR IN REPORTING WOULD OCCUR. BIOHIT PRODUCT LABELING INSTRUCTS THE CUSTOMER TO PERFORM QC DEPENDANT ON LABORATORY POLICY. CUSTOMER PERFORMED QC TEST, RECOGNISING ITS FAILURE THEY THEN DISCONTINUED THE USE OF THE PIPETTOR. NO FURTHER COMPLAINTS HAVE BEEN LOGGED ABOUT THIS PIPETTE SINCE THIS REPORTING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT PIPETTE WAS OBSERVED DISPENSING TOO MUCH FLUID DURING TESTING.

    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 *