FDA Adverse Event
Other
Summary report: N
RAPIDPOINT 500
MDR report key: 3071013
·
Received April 11, 2013
Report
- Report Number
- 1217157-2013-00064
- Event Type
- Other
- Date Received
- April 11, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 26, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- GKR
- PMA / PMN Number
- K113216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS ERROR WAS DETERMINED TO BE DUE TO THE USER ERROR WHEN THE PT ID WAS BEING ENTERED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT PT INFORMATION DISPLAYED ON THE ANALYZER SCREEN DID NOT MATCH THE INFORMATION THAT WAS SCANNED INTO THE INSTRUMENT. THERE WAS NO REPORT OR INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155306 | RAPIDPOINT 500 | RP500 | GKR | SIEMENS HEALTHCARE DIAGNOSTICS INC. | RP500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |