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

Model Number	MMT-923
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the infusion set's tubing detached at the quick release and the patient noticed insulin out of the tubing about twelve hours after changing the set.This issue occurred with two sets.Moreover, the catheter was in use for 2-3 days and the patient had redness on the skin as a sign of skin infection for over one week.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 10228753
• Report Number: 3003442380-2020-00316
• Device Sequence Number: 573943
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MMT-923
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/03/2020
• Patient Sequence Number: 1