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

Lot Number	5152541
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 on the day of this report, she changed her site at lunchtime.She worked, came home, sat on her desk and when she took it out of her pocket for dinner, the tubing was found detached from the quick release.The patient's blood glucose level at the time of incident was 74 mg/dl.The site location was near her belly button on the right side and the pump was in her right pocket.The infusion had been in use for four hours and the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.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 46/6 PCC BLUE
• MDR Report Key: 8653222
• Report Number: 3003442380-2019-01499
• Device Sequence Number: 2299061
• 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: 09/01/2019
• Device Lot Number: 5152541
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 05/30/2019
• Patient Sequence Number: 1