FDA Adverse Event
Other
Summary report: N
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
MDR report key: 740287
·
Received July 20, 2006
Report
- Report Number
- 2243072-2006-00267
- Event Type
- Other
- Date Received
- July 20, 2006
- Date of Event
- June 19, 2006
- Report Date
- July 19, 2006
- Manufacturer
- BECTON DICKINSON
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, 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 ERRATIC READINGS WITH HIS PLINK METER. ANALYSIS RUN ON CONSENSUS ERROR GRID (CEG) USING MEAN READINGS (326) AS REFERENCE POINT VS. BD READINGS (524, 128) 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 | 6064038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |