FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 1522879
·
Received October 30, 2009
Report
- Report Number
- 2250051-2009-00316
- Event Type
- Malfunction
- Date Received
- October 30, 2009
- Date of Event
- October 23, 2009
- Report Date
- October 29, 2009
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ORTHO FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE WAS UNABLE TO DUPLICATE THE ERROR. FSE INSPECTED THE PLUNGER CLAMPS AND TIP CLAMPS AND FOUND THEM TO BE IN GOOD CONDITION AS WELL AS ALL OTHER ACCESSORIES. INSTRUMENT IS WORKING AS EXPECTED, NO REPAIRS WERE NECESSARY.
Description of Event or Problem · 1
THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT DID NOT PIPETTE SAMPLE AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO SUMMIT SAMPLE HANDLING SYSTEM | SAMPLE PIPETTER | JTC | HAMILTON BONADUZ AG | 7003009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |