''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS
FDA device recall Z-0162-06 · posted 2005-11-18 · Terminated
Recall details
- Recalling firm
- Medtronic MiniMed
- Reason for recall
- The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure.
- Action taken
- All end users who recieved the model MMT-515 or MMT-715 pump that included the 'Fine Yuning Your Pump' workbook will be notified through a letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- Approximately 14,560
- Distribution
- Nationwide, Bahamas, Bermuda, Canada, Mexico, and Puerto Rico.
- Date initiated
- 2005-04-27
- Date posted
- 2005-11-18
- Date terminated
- 2007-03-20
- Location
- Northridge, CA
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