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

Lot Number 5248536

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 reported that she was hospitalized due to diabetic ketoacidosis.No further information available.

• Brand Name: MIO¿
• Type of Device: INSET II 60/6 PCC PINK
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8342405
• MDR Text Key: 136232653
• Report Number: 3003442380-2019-00550
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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

• 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: 5248536
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/15/2019
• Type of Device Usage: N
• Patient Sequence Number: 1