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

Model Number	MMT-965600
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
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 was not able to use the pump for three days due to insulin flow blocked alarm.This issue started three days ago, since then the patient has been using needles to manage her blood glucose levels.Moreover, she changed the infusion set and reservoir four times, but still faced the same issue.Reportedly, the patient was waiting to see her healthcare professional.She received the alarms during basal.At the time of the report, her blood glucose level was 29 mmol/l, and the patient was vomiting.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 PCC GREY MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14927367
• Report Number: 3003442380-2022-00833
• Device Sequence Number: 5813364
• Product Code: FPA
• UDI-Device Identifier: 05705244007819
• UDI-Public: 05705244007819
• 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): 07/06/2022

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 Expiration Date: 05/01/2020
• Device Model Number: MMT-965600
• Device Lot Number: 5195411
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2022
• Initial Report FDA Received Date: 07/06/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown