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

Model Number	MMT-941
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the (b)(6).It was reported that the patient's infusion set's tubing had disconnected at the connector while sleeping which led to high blood glucose levels.The site location was on her leg and the pump was on the same side as the set.The infusion had been used for two days.The infusions were in a cupboard in the house.She was unsure of any stress or pull on the tubing and was also unsure whether the pump was dropped with the set connected to her body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 9961238
• Report Number: 3003442380-2020-00245
• Device Sequence Number: 13638709
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• 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 Expiration Date: 08/01/2022
• Device Model Number: MMT-941
• Device Lot Number: 5290919
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1