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	Hypoglycemia (1912)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number: (b)(4).Event occurred in the (b)(6).On (b)(6) 2020, the patient's mother reported that her son's infusion set's tubing was disconnected from the quick release when they got it out of the box and it was not yet inserted.Moreover, on (b)(6) 2020 around 10:30 pm, he experienced low blood glucose level of 33 mg/dl, had weakness and his hands were cold.Further, this was prolonged to (b)(6) 2020, and they tried to treat it with food and glucose tablets.Reportedly, 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 patient's body.No further information available.
Event or Problem Description
On 09-oct-2020: follow up information was submitted as result of complaint investigation of the returned used device (1 set) showed that the glue in the tubing connector was missing (one drop of glue was found on connector).Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, the patient's mother reported that her son's infusion set's tubing was disconnected from the quick release when they got it out of the box and it was not yet inserted.Moreover, on (b)(6) 2020 around 10:30 pm, he experienced low blood glucose level of 33 mg/dl, had weakness and his hands were cold.Further, this was prolonged to (b)(6) 2020, and they tried to treat it with food and glucose tablets.Reportedly, 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 patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 10492902
• Report Number: 3003442380-2020-00376
• Device Sequence Number: 2939650
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 04/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5276359
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/09/2020
• Patient Sequence Number: 1