MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC PINK

Lot Number 5235875

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).Event occurred in (b)(6).The tubing of the infusion set detached at quick release.Reportedly, it was observed that the insulin came out of the tubing about 8-10 hours after the set was changed.No further information available.

• Brand Name: MIO¿
• Type of Device: INSET II 46/6 PCC PINK
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8193635
• MDR Text Key: 131306900
• Report Number: 3003442380-2018-00157
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007376
• UDI-Public: 05705244007376
• 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: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2021
• Device Lot Number: 5235875
• Date Manufacturer Received: 11/26/2018
• Type of Device Usage: N
• Patient Sequence Number: 1