FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 3241200
·
Received September 28, 2006
Report
- Report Number
- 2250051-2006-00414
- Event Type
- Malfunction
- Date Received
- September 28, 2006
- Date of Event
- August 31, 2006
- Report Date
- September 27, 2006
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- MMH
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND A DISPOSABLE TIP HITTING THE PLATE IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. THE TIP CLAMP WAS REPLACED. THE INSTRUMENT WAS CLEANED, INSPECTED, TESTED WITHOUT FURTHER PROBLEM, AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE/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. COMPLAINT NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO SUMMIT SAMPLE HANDLING SYSTEM | SAMPLE PIPETTOR | MMH | HAMILTON BONADUZ AG | 7003009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |