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Terminated

''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS

FDA Recall Z-0162-06 · Posted 2005-11-18

Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeLZG
Date Initiated2005-04-27
Date Terminated2007-03-20
Product QuantityApproximately 14,560

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Bahamas, Bermuda, Canada, Mexico, and Puerto Rico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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