FDA Adverse Event
Malfunction
Summary report: N
ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER
MDR report key: 822628
·
Received January 16, 2007
Report
- Report Number
- 1823260-2007-00484
- Event Type
- Malfunction
- Date Received
- January 16, 2007
- Date of Event
- December 17, 2006
- Report Date
- January 16, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- k961481
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION AND INVESTIGATION ONGOING.
Description of Event or Problem · 1
THE RESULT FOR TWO SAMPLES INDICATED A NEGATIVE TOXO IGM RESULT AS COMPARED TO POSITIVE RESULTS FROM IFA IGM AND A DIFFERENT DEVICE. ISSUE IS STILL BEING INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER | 2010 DISK - JJE | JJE | ROCHE DIAGNOSTICS | 2010 DISK | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |