FDA Adverse Event
Other
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 1387807
·
Received May 12, 2009
Report
- Report Number
- 2250051-2009-00151
- Event Type
- Other
- Date Received
- May 12, 2009
- Date of Event
- April 29, 2009
- Report Date
- May 12, 2009
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER DID NOT REQUEST SERVICE ACTIVITY. CUSTOMER TECHNICAL SERVICES REVIEWED THE CUSTOMER'S DATA FILES. INVESTIGATION INDICATES THAT THE CUSTOMER IS NOT USING AN OPTIMAL BARCODE SYMBOLOGY AND SYSTEM SETTING. THE CUSTOMER HAS BEEN INFORMED OF THE RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 1
THE BARCODE SCANNER ON THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM MISREAD THE SAMPLE BARCODE. A BARCODE MISREAD COULD RESULT IN A SAMPLE FROM ONE PT BEING MISINTERPRETED FOR ANOTHER. 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 |