FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 1456894
·
Received August 14, 2009
Report
- Report Number
- 2250051-2009-00255
- Event Type
- Malfunction
- Date Received
- August 14, 2009
- Date of Event
- August 11, 2009
- Report Date
- August 14, 2009
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) VERIFIED ALL TIP HOLD AND PULL FORCES MET SPECIFICATION. FSE FOUND X POSITION TIP TAKE UP OFF BY ONE STEP AND ALIGNED TIP TAKE UP. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM. INSTRUMENT IS OPERATING AS EXPECTED AND NO REPAIRS WERE NECESSARY.
Description of Event or Problem · 1
THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT DID NOT PIPETTE SAMPLE AND REAGENT 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 |