MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 PCC PINK MCAN

Model Number	MMT-921600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, it was reported that the patient's infusion set's tubing detached from the site.Therefore, her blood glucose level was 19 mmol/l at the time of the incident.Currently, her blood glucose level was 5.7 mmol/l.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 PCC PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14019201
• Report Number: 3003442380-2022-00515
• Device Sequence Number: 20347812
• Product Code: FPA
• UDI-Device Identifier: 05705244007390
• UDI-Public: 05705244007390
• 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): 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-921600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/06/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown