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

Lot Number 5243226

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 had issues with the infusion set which led to high blood glucose (over 500 mg/dl).She felt like she had flu and was not able to bring down the raised blood glucose although she kept trying to treat.Reportedly, she did not feel well, so went to bed but had no fever.Subsequently, she was diagnosed for diabetic ketoacidosis and was hospitalized for several days.She received insulin drip as a corrective treatment.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: 8360772
• MDR Text Key: 136846175
• Report Number: 3003442380-2019-00510
• 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: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2021
• Device Lot Number: 5243226
• Date Manufacturer Received: 12/20/2018
• Type of Device Usage: N
• Patient Sequence Number: 1