OtherFJD
BD PARADIGM LINK GLUCOSE MONITOR
Received Sep 10, 2004 · Event occurred Aug 11, 2004
Report 2243072-2004-00540 · MDR key 5351804
Device
Generic name
Bd Test Strips
Manufacturer
Becton DickinsonModel number
NACatalog number
322200
Lot number
3071343
Product problems
- False Reading From Device Non-Compliance
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AWAITING PRODUCT RETURN TO CONDUCT QUALITY INVESTIGATION.
Description of Event or Problem
CONSUMER CALLED TO REPORT PROBLEMS W/HER DAUGHTER'S METER. EXPERIENCING INACCURATE READINGS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (59) AS REF. POINT VS. BD READINGS (29, 89) YIELDED DATA POINTS IN THE C RANGE OF THE GRID, OUTSIDE OF ACCEPTABLE LIMITS.