OtherFJD
BD LOGIC BLOOD GLUCOSE MONITOR
Received Sep 10, 2004 · Event occurred Aug 12, 2004
Report 2243072-2004-00545 · MDR key 5351795
Device
Generic name
Bd Test Strips
Manufacturer
Becton DickinsonModel number
NACatalog number
322051
Lot number
3064062
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 HER METER IS GIVING INACCURATE READINGS, VERY ERRATIC. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (212 AS REF. POINT VS. BD READINGS (36, 269, 176, 270, 311) YIELDED DATA POINTS IN THE E RANGE OF THE GRID, OUTSIDE OF ACCEPTABLE LIMITS.