OtherFJD
BD PARADIGM LINK GLUCOSE MONITOR
Received Sep 10, 2004 · Event occurred Aug 12, 2004
Report 2243072-2004-00547 · MDR key 5351802
Device
Generic name
Bd Test Strips
Manufacturer
Becton DickinsonModel number
NACatalog number
322201
Lot number
3064100
Product problems
- High Readings
- Low Readings
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 HIGH AND LOW READINGS W/HER METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (67) AS REF. POINT VS. BD READINGS (30, 104) YIELDED DATA POINTS IN THE D RANGE OF THE GRID, OUTSIDE OF ACCEPTABLE LIMITS.