FDA Adverse Event
Other
Summary report: N
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
MDR report key: 763124
·
Received November 10, 2005
Report
- Report Number
- 2243072-2005-00461
- Event Type
- Other
- Date Received
- November 10, 2005
- Date of Event
- October 27, 2005
- Report Date
- November 10, 2005
- Manufacturer
- BECTON DICKINSON
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 METER IS INACCURATE. READINGS ARE VERY ERRATIC. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (178) AS REFERENCE POINT VS. BD READINGS (45, 230, 259) YIELDED SOME DATA POINTS IN THE C RANGE OF THE GRID, OUTSIDE ACCEPTABLE LIMITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD PARADIGM LINK BLOOD GLUCOSE MONITOR | BD TEST STRIPS | NBW | BECTON DICKINSON | NA | 5064145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |