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

Model Number	MMT-941
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Coma (2417)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Infusion set lot 5251213 reference samples have been investigated to be fully within specifications.Batch review has been performed and are within specifications.
Event or Problem Description
Unomedical reference: (b)(4).A male diabetic is treated with insulin via a medtronic insulin pump and a medtronic mio paradigm mmt-941 infusion set.He also uses a cgm sensor/transmitter.Note: he is new to pump and to cgms therapy.On (b)(6) 2019 he experience elevated blood glucose at 400 mg/dl followed by seizure.Ems takes patient to a hospital ((b)(6) hospital) where he is in coma for three days and remain hospitalized for two weeks.There are no data indicating any pump failure, infusion set failure or sensor/transmitter failure.In early june it is stated, that patient 'is still working with his physician to be more aggressive with his pump settings'.

• 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: 8792538
• Report Number: 3003442380-2019-00005
• Device Sequence Number: 1925726
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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 Expiration Date: 08/01/2021
• Device Model Number: MMT-941
• Device Lot Number: 5251213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/16/2019
• 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; Life Threatening
• Patient Weight: 161