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

Model Number	MMT-941600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/24/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The stated many set changes during 3-4 days may indicate patient having problems with either the infusion sets or having pump problems (i.E.The constant pump alarms resulted in the patient having removed his pump).Data does not allow making proper assessment of causal relationship between pump/dka and/or infusion set/dka.
Event or Problem Description
(b)(4).(b)(6).A widow reports to medtronic helpline that her husband passed away on (b)(6) 2018 after being admitted to hospital on (b)(6) 2018 with diabetic ketoacidosis (dka).Reportedly, physicians state cause of death as severe dka.It is reported that blood glucose (bg) had been high for the previous couple of days.A roommate informed that the pump was constantly alarming so the patient therefore removed the pump.It is reported that the patient for 3-4 days performed multiple daily (site/set) changes.No further information is available or expected.

• Brand Name: MIO
• Common Device Name: INSULIN PUMP INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, 4320 ; DA 4320
• MDR Report Key: 7662262
• Report Number: 3003442380-2018-00028
• Device Sequence Number: 14082071
• Product Code: FPA
• UDI-Device Identifier: 05705244007338
• UDI-Public: 05705244007338
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-941600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization