FDA Adverse Event
Other
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 68500
·
Received February 7, 1997
Report
- Report Number
- 2250051-1997-00002
- Event Type
- Other
- Date Received
- February 7, 1997
- Date of Event
- January 22, 1997
- Report Date
- February 7, 1997
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE RUNNING A HEPATITIS CORE ASSAY THE DEVICE PIPETTED ROW E IN ROW F, ROW F INTO ROW G AND ROW G INTO ROW H. ROW H WAS NOT PIPETTED AT ALL. NO ERROR MESSAGES WERE GENERATED. CO'S FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO SUMMIT SAMPLE HANDLING SYSTEM | SAMPLE HANDLER | JTC | HAMILTON BONADUZ AG | 135028 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |