MMT-712 PARADIGM Insulin Pump

Description of Event or Problem

It was reported to MiniMed that the customer experienced Hyperglycemia. Blood glucose value at the time of event was 29.8 mmol/L. The customer was treated with Insulin Pump (Subcutaneous Insulin Infusion). The event involved product(s) MMT-712EWS. Troubleshooting was performed. It is unknown whether the customer was using the Auto Mode/Smart Guard feature at the time of the event. The customer was using the insulin pump system within 48 hours of reported event. No further patient complications were reported. No product return is required for MMT-712EWS.

Additional Manufacturer Narrative

This MDR related to the Puerto Rico manufacturing site has been assigned a MedWatch number from the Medtronic MiniMed Northridge site, per Variance 5. Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. Select patient Information cannot be provided due to regional privacy regulations. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employees caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.