MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC MIO; INSULIN INFUSION SET

Model Number MMT-975

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/19/2018

Event Type  Death  

Manufacturer Narrative

The available case data does not indicate causal relation between death and any possible infusion set failure.No further information is expected to become available.

Event Description

(b)(4).An estranged wife calls medtronic helpline to informed that her husband passed away at home on (b)(6) 2018.It is not known if the husband was using insulin pump at time of death.Reporting person believes that cause of death was diabetic coma.Infusion set was a medtronic mio, model mmt-975 of unknown lot number.Further information is not provided and is not expected to become available.

• Brand Name: MEDTRONIC MIO
• Type of Device: INSULIN INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3, osted; lejre, 4320
• MDR Report Key: 7618385
• MDR Text Key: 111632763
• Report Number: 3003442380-2018-00024
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death