FDA Adverse Event
Other
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 123704
·
Received September 26, 1997
Report
- Report Number
- 2250051-1997-00092
- Event Type
- Other
- Date Received
- September 26, 1997
- Date of Event
- September 12, 1997
- Report Date
- September 26, 1997
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS ASSAY, SUMMIT SAMPLE HANDLER, MISREAD A SAMPLE BARCODE AS "017 KC50976" INSTEAD OF "017 KH45776". NO ERROR MESSAGE WAS GENERATED. AN ORTHO 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 |