MAUDE Adverse Event Report: MIO; INSET II 80/6 PCC GREY

Model Number	MMT-965
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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 united states.The patient reported that the infusion set came undone from her body while sleeping.Further, it was stated that the infusion set's tubing came apart, as it came out of the skin which led to high blood glucose levels.The site location was her stomach and the pump was located on the same side.The infusion had been used for maybe one day and they were stored in a dresser.There was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.Reportedly, the patient had a surgery (non-diabetic).No further information available.
Event or Problem Description
On (b)(6) 2020: follow up information was submitted because result of complaint investigation of the returned used device (2 set) showed that all test results were within specifications.Based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion sets came undone from her body while sleeping.Further, it was stated that the infusion set's tubing came apart, as it came out of the skin which led to high blood glucose levels.The site location was her stomach and the pump was located on the same side.The infusion had been used for maybe one day and they were stored in a dresser.There was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.Reportedly, the patient had a surgery (non-diabetic).No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 80/6 PCC GREY
• MDR Report Key: 9725608
• Report Number: 3003442380-2020-00175
• Device Sequence Number: 1964711
• Product Code: FPA
• UDI-Device Identifier: 05705244007796
• UDI-Public: 05705244007796
• 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,Followup

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-965
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/12/2020
• Patient Sequence Number: 1