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

Model Number	MMT-965
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.It was reported that the tube came out from where it was connected to the body (detached), although the tube from the pump was connected.Reportedly, the patient had high blood glucose levels of 250 mg/dl, as the insulin was not being delivered.The site location was his abdomen.They are unsure if there was any stress or pull on the tubing and were also unsure if the pump was dropped with the set connected to their body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC GREY
• MDR Report Key: 10090604
• Report Number: 3003442380-2020-00279
• Device Sequence Number: 11647853
• Product Code: FPA
• UDI-Device Identifier: 05705244007796
• UDI-Public: 05705244007796
• 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 Model Number: MMT-965
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/27/2020
• Patient Sequence Number: 1