FDA Adverse Event
Other
Summary report: N
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
MDR report key: 791515
·
Received November 15, 2006
Report
- Report Number
- 2243072-2006-00411
- Event Type
- Other
- Date Received
- November 15, 2006
- Date of Event
- October 15, 2006
- Report Date
- November 15, 2006
- Manufacturer
- BECTON DICKINSON
- Product Code
- NBW
- PMA / PMN Number
- k041478
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
VERIFICATION OF THE ACCURACY FOR THIS LOT WAS PERFORMED AGAINST THE CURRENT VERSION OF THE INSPECTION TEST PROCEDURE. LOT PASSED ALL CRITERIA OUTLINED IN THE TEST PROCEDURE. WILL CONTINUE TO MONITOR ON MONTHLY COMPLAINT TREND REPORTS.
Description of Event or Problem · 1
CONSUMER CALLED TO REPORT ERRATIC READINGS WITH THE BGM METER. ANALYSIS RUN ON CONSENSUS ERROR GRID USING MEAN READING (300) AS REFERENCE POINT VS. BD READINGS (230, 103, 569) YIELDED SOME DATA POINTS IN THE C ZONE OF THE GRID, OUTSIDE OF ACCEPTABLE RANGES.
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 | 6064067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |