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

Lot Number	5267074
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
(b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing came apart from the site itself as it got caught while she was removing her garments, which she stated was her own error.The patient's blood glucose level was reported to be 100 mg/dl.The site location was patient's thigh and the pump was located on the belt.Reportedly, the infusion had been in use for half a day and the infusions were stored at room temperature.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 8887019
• Report Number: 3003442380-2019-01696
• Device Sequence Number: 10819515
• 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 Expiration Date: 01/01/2022
• Device Lot Number: 5267074
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/13/2019
• Patient Sequence Number: 1