FDA Adverse Event
Summary report: N
LIFESCAN SURE STEP PRO
MDR report key: 2211338
·
Received August 11, 2011
Report
- Report Number
- 2211338
- Date Received
- August 11, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 11, 2011
- Manufacturer
- LIFESCAN
- Product Code
- CGA
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A STRIP WAS REMOVED FROM THE VIAL AND IT WAS NOTED THAT CONFIRMATION DOT WAS PALE BLUE PRIOR TO USE. THE BLUE COLOR IS NOT UNIFORM. APPEARS TO BE SLIGHTLY DARKER AT THE PERIMETER AND AT THE SIDE OF PAD WHERE BLOOD IS APPLIED. ALSO IT APPEARS TO HAVE A BLUE HUE. A TOTAL 14 STRIPS IN VIAL WERE AFFECTED. THE REMAINING 13 STRIPS HAD UNCHANGED, OFF WHITE CONFIRMATION DOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESCAN SURE STEP PRO | GLUCOSE POINT OF CARE TEST STRIPS | CGA | LIFESCAN | LIFESCAN SURE STEP PRO | 3112736008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |