FDA Adverse Event
Other
Summary report: N
RAPIDPOINT 1265
MDR report key: 3071011
·
Received April 11, 2013
Report
- Report Number
- 1217157-2013-00062
- Event Type
- Other
- Date Received
- April 11, 2013
- Date of Event
- March 27, 2013
- Report Date
- March 27, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- CHL
- PMA / PMN Number
- K031560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE OF THE ELEVATED NA+ AND C1- RESULTS IS UNKNOWN.
Description of Event or Problem · 1
CUSTOMER REPORTED ELEVATED SODIUM (NA+) AND CHLORIDE (C1- RESULTS ON THE RAPIDPOINT 1265 ANALYZER. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157220 | RAPIDPOINT 1265 | RAPIDPOINT 1265 | CHL | SIEMENS HEALTHCARE DIAGNOSTICS INC. | RP1265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |