MAUDE Adverse Event Report: MIO; UNO INSET II 80/9 PCC GREY MIMX

Model Number	MMT-975
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that, on (b)(6) 2020, the patient experienced high blood glucose level, therefore, the patient tried to treat it using insulin pump.Subsequently, on the same day at 01:00 pm, the patient was admitted to the hospital due to diabetic ketoacidosis and blood glucose level of 504 mg/dl.The patient stated, the infusion set fell out while sleeping.During hospitalization, the patient received intravenous insulin drip as corrective treatment.The patient was hospitalized for five days.Currently, patient's blood glucose level was 128 mg/dl.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 PCC GREY MIMX
• MDR Report Key: 10973697
• Report Number: 3003442380-2020-00477
• Device Sequence Number: 16352397
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• Combination Product (Y/N): Y
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: MMT-975
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/09/2020
• Patient Sequence Number: 1