FDA Adverse Event
Malfunction
Summary report: N
MTS PIPETTE
MDR report key: 856330
·
Received May 30, 2007
Report
- Report Number
- 9681721-2007-00009
- Event Type
- Malfunction
- Date Received
- May 30, 2007
- Date of Event
- April 30, 2007
- Report Date
- May 29, 2007
- Manufacturer
- BIOHIT OYJ
- Product Code
- JTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THAT THE BIOHIT PIPETTOR DISPENSED THE INCORRECT AMOUNT OF FLUID. NO DEFINITIVE ROOT CAUSE WAS DETERMINED. THE CUSTOMER OBSERVED THE ISSUE WHILE PIPETTING SAMPLE AND ABORTED TESTING, PREVENTING ERRONEOUS TEST RESULTS FROM BEING REPORTED. HOWEVER, IF THIS INCIDENT WERE TO OCCUR UNDETECTED, AN INCORRECT DISPENSE OF FLUID COULD LEAD TO VARIATION IN ANTIGEN / ANTIBODY RATION AND ERRONEOUS TEST RESULTS. THE CUSTOMER COMPLAINT WAS CONFIRMED. ISSUE RESOLVED THROUGH PRODUCT REPLACEMENT. THE PIPETTOR IN QUESTION WILL BE STAGED FOR FUTURE DISPOSITION ONCE EVALUATED BY THE DEPOT.
Description of Event or Problem · 1
CUSTOMERS BIOHIT PIPETTOR PROGRAM P3 IS NOT DISPENSING PROPERLY.
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 |