Recall Z-0162-06 ยท LZG Pump, Infusion, Insulin
Medtronic MiniMed
''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS
| Date | Nov 18, 2005 (initiated Apr 27, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | Approximately 14,560 |
| Distribution | Nationwide, Bahamas, Bermuda, Canada, Mexico, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.