FDA Adverse Event
Malfunction
Summary report: N
DPE MODULAR W/ID AND ISE600
MDR report key: 949931
·
Received April 13, 2007
Report
- Report Number
- 1823260-2007-02983
- Event Type
- Malfunction
- Date Received
- April 13, 2007
- Date of Event
- March 20, 2007
- Report Date
- April 13, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K953239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER EXPERIENCING IMPRECISION FOR SODIUM, POTASSIUM, AND CHLORIDE TESTING OVER A NUMBER OF MONTHS. THE FOLLOWING DATA WAS PROVIDED FOR SODIUM TESTING, ALL RESULTS IN MMOI/L, EACH SAMPLE RUN 3 OR 4 TIMES USING SAME METHODOLOGY, SAMPLE 1, INITIAL 138, REPEATS 130,131. SAMPLE 2, INITIAL 146, REPEATS 134,134. SAMPLE 3 INITIAL 136, REPEATS 131, 137, 137. SAMPLE 4 INITIAL 127, REPEATS 137, 137, 134. SAMPLE 5 INITIAL 119, REPEATS 139, 144, 140. SAMPLE 6 INITIAL 98, REPEATS 140, 141, 141. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DPE MODULAR W/ID AND ISE600 | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | MODULAR | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |