BEUDAMED
    FDA Adverse Event Other Summary report: N

    MTS PIPETTE

    MDR report key: 925327 · Received October 4, 2007

    Report

    Report Number
    9681721-2007-00016
    Event Type
    Other
    Date Received
    October 4, 2007
    Date of Event
    August 10, 2007
    Report Date
    October 5, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: INDICATES THAT INCORRECT VOLUMES DISPENSED INVOLVING THE BIOHIT PIPETTOR CONSTITUTE A POTENTIAL HEALTH AND SAFETY HAZARD. INDICATES THAT AN INCORRECT DISPENSE, UNDETECTED BY THE USER (I.E. NO ERROR MESSAGE POSTED) IS A REPORTABLE INCIDENT. THIS CONDITION MAY LEAD TO ERRONEOUS TEST RESULTS. 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 MANUFACTURER 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 MANUFACTURER GUIDELINES FOR SCHEDULED PREVENTIVE SERVICE. BATTERY LIFE CAN BE EXTENDED BY FAITHFUL CHARGING HABITS TO PRECLUDE PREMATURE FAILURE OR REGULAR PREVENTIVE CHECKUPS AT OEM FACILITIES COULD DETECT A DAMAGED CHARGING SYSTEM OR FAILURE OF OTHER ELECTRONIC AND OR MECHANICAL COMPONENTS DUE TO AGEING AND THE NORMAL WEAR AND TEAR INCURRED BY USE.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THE BIOHIT PIPETTOR WAS SET TO PROGRAM 9, HOWEVER, AFTER ONE DISPENSE THE PIPETTOR FLASHED AND THEN SWITCHED TO PROGRAM 1 DURING TESTING. THE CUSTOMER DISCONTINUED THE USE OF THE PIPETTOR. THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THIS INCIDENT. THE CUSTOMER INDICATED THAT THE BATTERY CONTACTS WERE CLEANED AND THE PIPETTOR WAS ALWAYS ON THE CHARGING STAND. CTS ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE PIPETTOR AND TO CONTACT THEIR OCD ACCOUNT MANAGER REGARDING THE OPTION TO PURCHASE A NEW PIPETTOR. THE PIPETTOR WAS OUT OF WARRANTY. THE CUSTOMER WAS DISSATISFIED THAT OCD DOES NOT PROVIDE SERVICE FOR PIPETTORS THAT ARE OUT OF WARRANTY. NO ERRONEOUS RESULTS WERE REPORTED. A SEARCH WAS PERFORMED CONCERNING COMPLAINTS LOGGED BY THIS CUSTOMER. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS PIPETTOR SINCE THE INCIDENT.

    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