FDA Adverse Event
Malfunction
Summary report: N
3 MODULE CORE WITH ISE600
MDR report key: 892632
·
Received April 23, 2007
Report
- Report Number
- 1823260-2007-03203
- Event Type
- Malfunction
- Date Received
- April 23, 2007
- Date of Event
- April 5, 2007
- Report Date
- April 20, 2007
- Manufacturer
- ROCHE DIAGNOSTICS CORP.
- Product Code
- JJE
- PMA / PMN Number
- K953239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCOUNT REPORTED THAT THEY WERE HAVING ISE PRECISION PROBLEMS AND GAVE FOUR EXAMPLES (INITIAL RESULT/REPEAT RESULT) SAMPLE 1 NA: 231/134, K: 7.4/3.6. SAMPLE TWO K: 9.5/4.8. SAMPLE THREE K: 3.7/3.0. SAMPLE FOUR K: 4.6/3.9. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SVC REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3 MODULE CORE WITH ISE600 | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS CORP. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |