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

Model Number	MMT-923
Medical Device Problem Code	Material Twisted/Bent (2981)
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.On (b)(6) 2021, the patient reported that her last two infusion sets have had bent cannulas.Reportedly, on (b)(6) 2021 at 1:00 pm, she was admitted to the hospital due to blood glucose level of 780 mg/dl and diabetic ketoacidosis.Currently, her blood glucose level was 271 mg/dl and experienced diabetic ketoacidosis.She was treated with some unspecified drug intravenously (drug name unknown) and was currently in the hospital (at the time of this report).No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 PCC PINK MIMX
• MDR Report Key: 12251451
• Report Number: 3003442380-2021-00341
• Device Sequence Number: 14702844
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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-923
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/30/2021
• Patient Sequence Number: 1