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

Model Number MMT-945

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

N/a.

Event 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
• 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: 11811724
• MDR Text Key: 250186002
• Report Number: 3003442380-2021-00002
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-945
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/12/2021
• 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