BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 836991 · Received February 23, 2007

    Report

    Report Number
    9681721-2007-00005
    Event Type
    Malfunction
    Date Received
    February 23, 2007
    Date of Event
    January 3, 2007
    Report Date
    February 21, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE BIOHIT PIPETTOR DID NOT FUNCTION PROPERLY, NOT DISPENSING THE CORRECT AMOUNT OF FLUID. NO DEFINITIVE ROOT CAUSE WAS DETERMINED. THE CUSTOMER ABORTED ALL TESTING, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED. BIOHIT PRODUCT LABELING INSTRUCTS THE CUSTOMER TO PERFORM QC DEPENDANT ON LAB 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 INCORRRECT AMOUNT OF VOLUME, QC WILL FAIL, PREVENTING TESTING FROM OCCURRING, AND ERRONEOUS RESULTS FROM BEING REPORTED. CUSTOMER ISSUE RESOLVED VIA PRODUCT REPLACEMENT. THE CUSTOMER COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    PIPETTE IS REPORTED TO NOT BE FUNCTIONING PROPERLY. PIPETTE SOMETIMES DISPENSES LESS THAN CORRECT VOLUMES AND SOMETIMES WORKS FINE BUT SLOW. (AS OBSERVED) WHEN DISPENSING, CUSTOMER INDICATED HEARING A NOISE COMING FROM THE PIPETTE.

    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 *