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Medtronic-BD MiniMed Pro-Set Shipments Temporarily Halted

By Brian Levine and Adam Brown

Limited launch unearthed complaints related to kinking and elevated blood glucose levels; however, majority of users said they would reorder

In January, Medtronic sent a one-page letter to about 500 customers taking part in the limited launch of the new MiniMed Pro-set pump infusion set with BD’s FlowSmart technology. The letter detailed how Medtronic received a “higher than expected” number of complaints related to kinked cannulas and elevated blood glucose levels. As a result, shipments of the set have stopped as Medtronic and BD integrate feedback and work on improving the product.

For those participating in the limited launch, Medtronic will replace any MiniMed Pro-sets. Use this online form or call 866-222-7304 to learn more. If no problems have been experienced, it is fine to continue using the Pro-set, though Medtronic recommends:

  • Reviewing the online learning instructions;

  • Using the MiniMed Quick-serter insertion device (instead of manual insertion);

  • Following the instructions for use provided with the product;

  • And continuing to monitor blood sugars frequently.

In his initial test drive of the set, diaTribe’s Adam Brown experienced kinking and high blood sugars due to problems associated with manual insertion and, admittedly, to not reading the instructions! The BD team shared with Adam that manual insertion requires a fast motion (not slow like a pen needle) and a 90-degree insertion angle – the automatic Quick-serter does a good job of ensuring both. This was a great point to hear. Adam is of two minds on the instructions – theoretically, of course, all users should be encouraged to read instructions, though many users do not, so easy-to-use and clear information is great to have, too.

Despite these issues, it is great to see that Medtronic and BD planned a gradual product roll-out to gather feedback about the set’s performance in the real world. Testing devices in varied settings is essential (e.g., hot showers, overnight, different wear locations and body types), and it is not uncommon to discover issues not previously identified in clinical trials. Both teams have taken the feedback very seriously.

BD is still optimistic about the Pro-set, having referred to it as a “key launch” at a recent conference. Previous estimates expected the “full” product launch to come around March 2017, though it could still be pushed back further.
 

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