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

Model Number	MMT-923
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, it was reported that while the patient was sleeping, the pink plastic part separated from the cord and her site pulled out, she was tossing and turning more in the past month and the cord detach from the quick release.Moreover, the entire site pulled out at one point both things happened to one site this morning with patient's blood glucose level of 153 mg/dl.When this issue occurred one time, her blood glucose level ranged between 260-280 mg/dl.The site location was patient's buttock and the pump was attached to the waist band.The infusion set had been used for at least a day.Reportedly, the infusions were stored in a drawer and in purse.The patient was unsure whether there was any stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC PINK
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16377731
• Report Number: 3003442380-2023-00164
• Device Sequence Number: 15034521
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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
• Device Model Number: MMT-923
• Device Lot Number: 5253560
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/15/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown