FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00417
MDR report key: 1243523
·
Received August 28, 2008
Report
- Report Number
- 2250051-2008-00417
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Product Code
- JJE
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. INSTRUMENT IS WORKING AS EXPECTED. ACCOUNT MANAGER REVIEWED TEST TRACE FILES AND DETERMINED THAT THE LAB TECH LOADED THE INCORRECT PLATE (ID# BK 0151) ONTO THE ORTHO SUMMIT PROCESSOR. CUSTOMER MEANT TO PLACE PLATE ID# BK0166 ONTO OSP, PHYSICALLY REMOVED PLATE BK0151 FROM THE ENTRY STACK AFTER PLATE BARCODE WAS SCANNED, AND REPLACED IT WITH THE CORRECT PLATE. THE PLATE WAS ABORTED DUE TO A WASH ERROR. NO ERRONEOUS RESULTS WERE REPORTED. REVIEWED GENERAL WARNINGS AND PRECAUTIONS SECTION IN OSP USER'S GUIDE WITH THE CUSTOMER. CUSTOMER INSTRUCTED NEVER TO REACH INTO THE INSTRUMENT DURING PROCESSING TO REMOVE PLATES DUE TO POTENTIAL FOR INJURY OR SAMPLE MISIDENTIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JJE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |