MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC BLUE

Lot Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient stated that a couple of weeks before this report, he had high blood glucose level reported to be more than 560 mg/dl at the time of incident along with symptoms including vomiting/ nausea.The night before, the patient had changed the set and received no insulin throughout the night.He was hospitalized for diabetic ketoacidosis and received insulin drip as corrective treatment till he was stable.The patient was hospitalized for two days.His blood glucose level at time of this report was more than 60 mg/dl.No further information available.

• Brand Name: MIO¿
• Type of Device: INSET II 60/6 PCC BLUE
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8534952
• MDR Text Key: 142606800
• Report Number: 3003442380-2019-01220
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/31/2017
• Type of Device Usage: N
• Patient Sequence Number: 1