FDA Adverse Event
Other
Summary report: N
ASCENSIA CONTOUR
MDR report key: 788131
·
Received November 28, 2006
Report
- Report Number
- MW1041169
- Event Type
- Other
- Date Received
- November 28, 2006
- Manufacturer
- BAYER HEALTHCARE, LLC, DIABETES CARE DIV.
- Product Code
- NBW
- Report Source
- Voluntary report
- Reporter Location
- RI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IN-VITRO (METER) DIAGNOSTIC USE REAGENTS TEST STRIPS 6% W/N PQQ GLUCOSE DEHYDROGENASE? 55% W/N POTASSIUM FERRICYANIDE? 39% W/N NON-REACTIVE INGREDIENTS? TESTING 3X DAY THEN 3X WK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA CONTOUR | BAYER | NBW | BAYER HEALTHCARE, LLC, DIABETES CARE DIV. | * | GCB3C06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |