FDA Adverse Event
Malfunction
Summary report: N
HITACHI 912
MDR report key: 686840
·
Received March 8, 2006
Report
- Report Number
- 1823260-2006-01135
- Event Type
- Malfunction
- Date Received
- March 8, 2006
- Date of Event
- February 21, 2006
- Report Date
- February 22, 2006
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL RESULT FOR A PT ISE WAS 112/102/4.5 FOR NA/CL/K. WHEN REPEATED, THE RESULT WERE 125/91/4.9 RESPECTIVELY. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP. WAS UNABLE TO CONFIRM ANY MALFUNCTION OF THE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HITACHI 912 | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS | 912 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |