OtherFJD
BD PARADIGM LINK GLUCOSE MONITOR
Received Sep 10, 2004 · Event occurred Aug 11, 2004
Report 2243072-2004-00543 · MDR key 5351790
Device
Generic name
Bd Test Strips
Manufacturer
Becton DickinsonModel number
NACatalog number
322200
Lot number
3064037
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 STATE HE DOESN'T LIKE THE READINGS HE IS RECEIVING W/HIS METER. BELIEVES THEM TO BE INACCURATE AND VERY ERRATIC. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (69) AS REF. POINT VS. BD READINGS (78, 25, 99, 73) YIELDED DATA POINTS IN THE D RANGE OF THE GRID, OUTSIDE OF ACCEPTABLE LIMITS.