FDA Adverse Event
Malfunction
Summary report: N
MTS ID TIPMASTER PIPETTOR
MDR report key: 870914
·
Received June 27, 2007
Report
- Report Number
- 1056600-2007-00182
- Event Type
- Malfunction
- Date Received
- June 27, 2007
- Date of Event
- May 29, 2007
- Report Date
- June 26, 2007
- Manufacturer
- MICRO TYPING SYSTEMS, INC.
- Product Code
- GJG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PIPETTE IS NO LONGER COVERED UNDER WARRANTY. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE USE OF THIS INSTRUMENT. THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION, AND THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT MTS ID TIPMASTER PIPETTOR DRIPPED FLUID. FLUID DRIP FROM THE PIPETTOR CAN LEAD TO CARRY OVER / CROSS CONTAMINATION AND INCORRECT DISPENSE OF FLUID WHICH MAY LEAD TO VARIATIONS IN ANTIGEN / ANTIBODY RATIO AND POSSIBLE ERRONEOUS TEST RESULTS. THE CUSTOMER OBSERVED THE ISSUE AND TOOK THE PIPETTOR OUT OF USE, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MTS ID TIPMASTER PIPETTOR | MANUAL PIPETTOR | GJG | MICRO TYPING SYSTEMS, INC. | NA | AN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |