FDA Adverse Event
Other
Summary report: N
RAPIDPOINT 405
MDR report key: 1343936
·
Received March 13, 2009
Report
- Report Number
- 1217157-2009-00001
- Event Type
- Other
- Date Received
- March 13, 2009
- Date of Event
- February 19, 2009
- Report Date
- February 19, 2009
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LTD.
- Product Code
- GKR
- PMA / PMN Number
- K020616
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THE SPECIMEN IN QUESTION WAS OBTAINED USING AN INCOMPLETELY FILLED SYRINGE. FURTHERMORE, THE NEWBORN DID NOT DISPLAY ANY SYMPTOMS CONSISTENT WITH A LOW SODIUM AND LOW CALCIUM . INSTRUMENT IS PERFORMING CORRECTLY.
Description of Event or Problem · 1
CUSTOMER REPORTED A SODIUM RESULT TAKEN IN THE MORNING ON A NEWBORN ((B)(6)) WAS REPORTED AS 138 MMOL/L. A SUBSEQUENT SAMPLE FROM THE SAME NEWBORN TAKEN LATER THAT DAY REPORTED A RESULT OF 126.7 MMOL/L. INSTRUMENT CALIBRATION WAS CHECKED AND CONTROLS WERE RUN ON THE DEVICE. BOTH WERE WITHIN NORMAL RANGE. THE SPECIMEN IN QUESTION ALSO YIELDED AN ABNORMALLY LOW CALCIUM. THERE WAS NO PT INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDPOINT 405 | RAPIDPOINT 405 | GKR | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LTD. | 405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |