BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 824564 · Received February 8, 2007

    Report

    Report Number
    9681721-2007-00004
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    December 11, 2006
    Report Date
    February 7, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THIS PIPETTE DID NOT DISPENSE THE CORRECT AMOUNT OF FLUID. NO DEFINITIVE ROOT CAUSE WAS DETERMINED, AND THE CUSTOMER ABORTED ALL TESTING, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED. BIOHIT PRODUCT LABELING INSTRUCTS THE CUSTOMER TO PERFORM QC DEPENDANT ON LABORATORY POLICY. MTS GEL CARD LABELING INSTRUCTS THE CUSTOMER TO PERFORM DAILY USE QC PRIOR TO TESTING. IF THE PIPETTOR'S VOLUME DELIVERY IS SIGNIFICANTLY INACCURATE OR THE PIPETTOR CONSISTENTLY DISPENSES A SIGNIFICANTLY INCORRECT AMOUNT OF VOLUME, QC WILL FAIL. PREVENTING TESTING FROM OCCURRING, AND ERRONEOUS RESULTS BEING REPORTED. CUSTOMER ISSUE RESOLVED VIA PRODUCT REPLACEMENT. THE CUSTOMER COMPLAINT HAS NOT BEEN CONFIRMED TO DATE, AS THE PIPETTOR HAS NOT BEEN EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE PIPETTE DREW LIQUID AND THEN DISPENSED THE FULL VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS PIPETTE ELECTRONIC PIPETTOR JTC BIOHIT OYJ 701142MT *

    Patients

    Seq Age Sex Outcome Treatment
    1 *