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

Model Number	MMT-943
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, a child patient's mother reported that six of the infusion set's tubing had detached from the site connector, and it happened about a week and a half ago.The site location was at the patient's abdomen and the infusion had been used for two days.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Reportedly, they had no idea how it had happened, but cut was pretty sure it was not because of a bent / or kinked tubing.Currently, the patient's blood glucose level was 300 mg/dl.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 10243407
• Report Number: 3003442380-2020-00317
• Device Sequence Number: 13601755
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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: 12/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5303388
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1