FDA Adverse Event
Malfunction
Summary report: N
ADDITIONAL D MODULE
MDR report key: 957493
·
Received November 28, 2007
Report
- Report Number
- 1823260-2007-10279
- Event Type
- Malfunction
- Date Received
- November 28, 2007
- Date of Event
- November 8, 2007
- Report Date
- November 28, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K953239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
NINE PATIENT SAMPLES RECOVERED INITIALLY WITH HIGH IRON RESULTS; SAME SAMPLES REPEATED WITH LOWER VALUES. PATIENT INITIAL RESULT IN UG/DL REPEATED RESULT IN UG/DL. PATIENT #1. 139/60, PATIENT #2. 101/30, PATIENT #3. 160/98, PATIENT #4. 151/67, PATIENT #5. 127/43, PATIENT #6. 105/27, PATIENT #7. 144/62, PATIENT #8. 105/27, PATIENT #9. 181/110. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES. THE FIELD SERVICE REPRESENTATIVE REPLACED THE STIR PADDLE, REAGENT AND SAMPLE SYRINGE SEALS, CLEANED THE WASH STATIONS, MSV PLATES AND RINSE UNIT NOZZLES. PRECISION CHECKS WERE PERFORMED, RECOVERED WITHIN SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADDITIONAL D MODULE | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | MODULAR D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |