FDA Adverse Event
Other
Summary report: N
BD LOGIC BLOOD GLUCOSE MONITOR
MDR report key: 764082
·
Received November 4, 2005
Report
- Report Number
- 2243072-2005-00425
- Event Type
- Other
- Date Received
- November 4, 2005
- Date of Event
- October 5, 2005
- Report Date
- November 2, 2005
- Manufacturer
- BECTON DICKINSON
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AWAITING PRODUCT RETURN TO CONDUCT QUALITY INVESTIGATION.
Description of Event or Problem · 1
CONSUMER CALLED TO REPORT TESTING BACK TO BACK AND HAVING VERY ERRATIC READINGS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (287) AS REFERENCE POINT VS. BD READINGS (460, 332, 233, 123) YIELDED SOME DATA POINTS IN THE C/D RANGE OF THE GRID, OUTSIDE ACCEPTABLE LIMITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD LOGIC BLOOD GLUCOSE MONITOR | BD TEST STRIPS | NBW | BECTON DICKINSON | NA | 4064076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |