FDA Adverse Event
Other
Summary report: N
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
MDR report key: 817863
·
Received November 15, 2004
Report
- Report Number
- 2243072-2004-00681
- Event Type
- Other
- Date Received
- November 15, 2004
- Date of Event
- October 17, 2004
- Report Date
- November 12, 2004
- Manufacturer
- BECTON DICKINSON
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 INACCURATE READINGS WITH HER PLINK METER. THE METER IS GIVING VERY ERRATIC RESULTS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (378) AS REFERENCE POINT VS. BD READINGS (200, 550, 385) YIELDED DATA POINTS IN THE C ZONE 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 | 3064293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |