FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 2213896
·
Received August 17, 2011
Report
- Report Number
- 2250051-2011-00208
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 17, 2011
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- MMH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 BROKEN PLUNGER CLAMP ON THE X-ARM. THE FSE REPLACED THE PLUNGER CLAMP AND LLD SPRING. THE FSE CHECKED THE X-ARM CALIBRATION AT TIP PICK-UP. 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 | MMH | HAMILTON BONADUZ AG | 936400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |