FDA Adverse Event
Other
Summary report: N
ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM
MDR report key: 120201
·
Received September 15, 1997
Report
- Report Number
- 2250051-1997-00085
- Event Type
- Other
- Date Received
- September 15, 1997
- Date of Event
- August 21, 1997
- Report Date
- September 15, 1997
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A WHILE RUNNING AN HTLV-I ASSAY, SUMMIT SAMPLE HANLDER, PIPETTED A BUBLE INTO A WELL IN ROW H AND DID NOT GIVE AN ERROR MESSAGE. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO DIAGNOSTIC SYSTEMS COMPLAINT NUMBER 97-04241-08.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM | SAMPLE HANDLER | JTC | HAMILTON BONADUZ AG | 135028 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |