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

Model Number MMT-941

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 05/21/2019

Event Type  Injury  

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 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
• 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: 8792538
• MDR Text Key: 151119968
• Report Number: 3003442380-2019-00005
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• 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: 07/16/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Model Number: MMT-941
• Device Lot Number: 5251213
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/16/2019
• 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): Hospitalization; Life Threatening
• Patient Weight: 161