FDA Adverse Event
Other
Summary report: N
RAPIDPOINT 405
MDR report key: 3031927
·
Received March 25, 2013
Report
- Report Number
- 1217157-2013-00043
- Event Type
- Other
- Date Received
- March 25, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS,
- Product Code
- CHL
- PMA / PMN Number
- K002738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INFO PROVIDED, THE INCORRECT PT ID WAS ENTERED MANUALLY.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE OPERATOR MANUALLY ENTERED A PT'S DEMOGRAPHIC INFO BECAUSE THE SAMPLE TUBE DID NOT HAVE A BARCODE. AFTER THE RESULTS WERE GENERATED AND SENT TO THEIR LIS SYSTEM, THE CUSTOMER REPORTED THAT THE SAMPLE HAD THE INCORRECT PT ID AND NAME. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121786 | RAPIDPOINT 405 | RAPIDPOINT 405 | CHL | SIEMENS HEALTHCARE DIAGNOSTICS, | RP405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |