FDA Adverse Event
Other
Summary report: N
RAPIDPOINT 405 SYSTEM
MDR report key: 1749113
·
Received June 29, 2010
Report
- Report Number
- 1217157-2010-00019
- Event Type
- Other
- Date Received
- June 29, 2010
- Date of Event
- June 4, 2010
- Report Date
- June 13, 2010
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
- Product Code
- MQM
- PMA / PMN Number
- K
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SYSTEM LOG FILES AND SENSOR LOG FILES WERE REVIEWED; NO INSTRUMENT ERRORS WERE IDENTIFIED. SENSOR LOG FILES SHOWED NO ABNORMALITIES AND QCS RUN ON THE DAYS OF THE EVENTS WERE ALL WITHIN RANGE. CALIBRATIONS AND QC WERE CORRECT. THE SYSTEM IS PERFORMING WITHIN SPECIFICATION.
Description of Event or Problem · 1
CUSTOMER COMPLAINED ABOUT THE PERFORMANCE OF THE TOTAL HEMOGLOBIN ON THREE SAMPLES WHICH GAVE DISCREPANT RESULTS VS. CLINICAL PICTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDPOINT 405 SYSTEM | RAPIDPOINT 405 SYSTEM | MQM | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. | RP 405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |