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

Model Number MMT-941600

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Diabetic Ketoacidosis (2364)

Event Date 05/24/2018

Event Type  Death  

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 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
• Type of Device: INSULIN PUMP 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: 7662262
• MDR Text Key: 113154547
• Report Number: 3003442380-2018-00028
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007338
• UDI-Public: 05705244007338
• 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: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization