FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 1984600
·
Received February 11, 2011
Report
- Report Number
- 2250051-2011-00028
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 11, 2011
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT. THE FSE FOUND A BAD TIP CLIP. THE FSE REPLACED THE TIP CLIP AND LOADED TIPS SEVERAL TIMES WITHOUT ERROR. THE FSE PERFORMED SPLLD CHECKING PROCEDURE AND TESTED SUMMIT WITH OAS USER SOFTWARE. THE INSTRUMENT WAS TESTED WITHOUT PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.
Description of Event or Problem · 1
THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE AND REAGENT AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. (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 | 936400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |