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

Model Number	MMT-945
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Coma (2417)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
Unomedical reference: (b)(4).A diabetic is treated with insulin via a medtronic insulin pump and a medtronic minimed mio blue mmt-945 infusion set.The infusion set is manufactured by unomedical a/s.On (b)(6) 2021 the patient experience elevated blood glucose at 1200 mg/dl followed by a fall and concussion, patient calls ems and then experience coma.Patient is taken to er where he is hospitalised at grove city hospital and was in coma for six days.Patient claims that the hyperglycemia and the fall is caused by the infusion set which unknowingly detached.At the medtronic helpdesk the suggested troubleshooting regarding the detachment is declined by the patient.Duration of the use of the infusion set in question is unknown to the patient.Lot/batch number is unknown.No further details are available.Causality, in particular to the coma, remains somewhat unclear.

• Brand Name: MIO
• Common Device Name: INSULIN INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, 4320 ; DA 4320
• MDR Report Key: 11811724
• Report Number: 3003442380-2021-00002
• Device Sequence Number: 3223498
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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-945
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/12/2021
• 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: Hospitalization