FDA Adverse Event
Summary report: N
STATSTRIP XPRESS
MDR report key: 2822933
·
Received November 2, 2012
Report
- Report Number
- 2822933
- Date Received
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- NOVA BIOMEDICAL
- Product Code
- CGA
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
IN PROCESS OF PERFORMING POINT-OF-CARE (POC) GLUCOSE TESTING WITH GLUCOSE METER, PERSONNEL ENCOUNTERS STRIP ERRORS THAT REQUIRE AN ADDITIONAL SAMPLE(S) TO BE TAKEN FROM THE PATIENT TO GET A GLUCOSE RESULT. THIS EVENT FAILURE HAPPENS FREQUENTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STATSTRIP XPRESS | GLUCOSE OXIDASE, GLUCOSE | CGA | NOVA BIOMEDICAL | * | 0312003249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |