BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 938060 · Received April 13, 2007

    Report

    Report Number
    9681721-2007-00007
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    February 20, 2007
    Report Date
    April 13, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED, THAT THE BIOHIT PIPETTOR DID NOT ASPIRATE THE CORRECT AMOUNT OF FLUID. NO DEFINITIVE ROOT CAUSE WAS DETERMINED. IT IS UNK WHICH TESTING WAS PERFORMED AT THE TIME OF THE INCIDENT. 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. THE CUSTOMER DID NOT STATE THAT AN INCORRECT AMOUNT OF FLUID WAS BEING DISPENSED. CUSTOMER ISSUE RESOLVED VIA PRODUCT REPLACEMENT. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BY OCD REPAIR DEPOT SINCE THE LCD WAS BLANK AND THE UNIT WAS NOT RESPONDING. THE PIPETTE WAS NOT SENT TO THE MFR FOR EVALUATION.

    Description of Event or Problem · 1

    AS PER MXP: "MTS BIOHIT PIPETTOR IS NOT ASPIRATING THE RIGHT AMOUNT OF FLUID. SOMETIMES IT PULLS UP MORE, SOMETIMES IT PULLS UP A LITTLE." AT THIS POINT, CUSTOMER REQUESTED A REPLACEMENT.

    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 *