FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 1541922
·
Received November 6, 2009
Report
- Report Number
- 2250051-2009-00321
- Event Type
- Malfunction
- Date Received
- November 6, 2009
- Date of Event
- October 26, 2009
- Report Date
- November 9, 2009
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ORTHO FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE REPLACED THE TIP CLAMP IN POSITION #1 AND CLEANED THE EJECT SLEEVE. FSE PERFORMED SPLLD CHECKING PROCEDURE AND RAN SUMMIT BOOT TEST. ALL TEST PASSED. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND RETURNED TO EXPECTED OPERATION.
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 |