FDA Adverse Event
Other
Summary report: N
ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM
MDR report key: 122785
·
Received September 24, 1997
Report
- Report Number
- 2250051-1997-00089
- Event Type
- Other
- Date Received
- September 24, 1997
- Date of Event
- August 22, 1997
- Report Date
- September 22, 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 WHILE RUNNING AN HTLV-I ASSAY USING SUMIT SAMPLE HANDLER, THERE WAS A BUBBLE OBSERVED IN ROW H AND NO ERROR MESSAGE WAS GENERATED. 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 97-04268-08.
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 |