MAUDE Adverse Event Report: MIO; UNO INSET II 80/6 SC1 GREY MCAN

Model Number	MMT-965A600
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, the patient's father reported that his daughter received insulin flow block this morning (3:00 am).Reportedly, she felt weak, tired and had headache.At the time of incident, her blood glucose level was 16 mmol/l and ketones were 1.5 mmol/l, which they corrected manually with a needle.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 SC1 GREY MCAN
• MDR Report Key: 12679482
• Report Number: 3003442380-2021-00621
• Device Sequence Number: 1206390
• Product Code: FPA
• UDI-Device Identifier: 05705244020399
• UDI-Public: 05705244020399
• 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
• Report Date (Section B): 10/22/2021

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: 03/01/2023
• Device Model Number: MMT-965A600
• Device Lot Number: 5313464
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/22/2021
• Usage of Device: N
• Patient Sequence Number: 1