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

Model Number	MMT-965A600
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 canada.On (b)(6) 2022, the patient's mother reported that her daughter received an insulin flow block on (b)(6) 2022.Her daughter had high blood glucose level in the night, and they changed the site five times, as she faced some bent cannula and at other events and insulin flow block.At the time of the incident, her blood glucose level was 27.7 mmol/l.Reportedly, it happened four days ago, and her mother stated that she was certain it was the infusion set cannula that was defective.Moreover, her mother had given needle as they had no tubing available and could not order it as it was closed on the weekend.Currently, her blood glucose level was 6.7 mmol/l.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 SC1 GREY MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15011189
• Report Number: 3003442380-2022-00862
• Device Sequence Number: 16723664
• 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): 07/14/2022

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
• Device Expiration Date: 06/01/2024
• Device Model Number: MMT-965A600
• Device Lot Number: 5355969
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/14/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown