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

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.The patient reported that she experienced vomiting, abdominal pain, was very tired and had positive results in ketone test.She stated that her pump smelt like insulin and her set was not sticking correctly and this might be the reason why her pump was not delivering insulin.Reportedly, the tape did not stick to her skin properly.Subsequently, on (b)(6) 2020, she was admitted to the hospital due to diabetic ketoacidosis and her blood glucose level at that time was 750 mg/dl.During hospitalization, she was treated for her high blood glucose levels and she stayed there for three days.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/9 PCC GREY
• MDR Report Key: 9669211
• Report Number: 3003442380-2020-00149
• Device Sequence Number: 16841908
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/01/2021
• Device Model Number: MMT-975
• Device Lot Number: 5255835
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1