Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
- Company
- Abbott Diabetes Care, Inc.
- Recall Initiated
- April 14, 2009
- Posted
- April 30, 2010
- Terminated
- March 31, 2011
- Recall Number
- Z-1458-2010
- Quantity
- 5,449 of total units
- Firm Location
- Alameda, CA
Reason for Recall
Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
Distribution
Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.
Lot / Code Info
Abbott Item # PRT 03415-010 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0878 or 01M3018. Kit Serial numbers beginning with: BAAH 067 BAAH 093 or BAAH 107 or BAAH 156 or BAAH 200 or BAAH 207 or BAAH 275 or BAAH 290 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 288 and followed by a five (5) digit number.
Root Cause
Process control
Action Taken
Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.