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

Model Number	MMT-945
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 united states.The patient reported that he noticed that as he had high blood glucose levels, so he checked the infusion set's tubing which had disconnected from the quick release while sitting.The site location was on the left side of his abdomen and the pump was located on the left side.The infusion set was used for one hour.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Further, there was not stress or pull on the tubing and the pump was not dropped with the set connected to his body.No further information available.
Event or Problem Description
On (b)(6) 2020: follow up information was submitted because a visual inspection and test for static pull was performed of the returned used device (1 tubing) and the result of complaint investigation showed that the tubing was detached from the tubing connector (missing glue).Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that he noticed that as he had high blood glucose levels, so he checked the infusion set's tubing which had disconnected from the quick release while sitting.The site location was on the left side of his abdomen and the pump was located on the left side.The infusion set was used for one hour.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Further, there was not stress or pull on the tubing and the pump was not dropped with the set connected to his body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC BLUE
• MDR Report Key: 9919525
• Report Number: 3003442380-2020-00232
• Device Sequence Number: 3374751
• Product Code: FPA
• UDI-Device Identifier: 05705244007734
• UDI-Public: 05705244007734
• 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 Expiration Date: 04/01/2022
• Device Model Number: MMT-945
• Device Lot Number: 5267155
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1