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

Model Number	MMT-975
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021 , it was reported that the patient's infusion set's tubing broke off when she was trying to put on.It happened three days ago, and the patient was unsure of her blood glucose levels.Upon investigation of the returned used device (one set), it was found that the glue in the tubing connector was missing.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 PCC GREY MIMX
• MDR Report Key: 11699492
• Report Number: 3003442380-2021-00219
• Device Sequence Number: 3436305
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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

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
• Operator of Device: No Information
• Device Expiration Date: 12/01/2022
• Device Model Number: MMT-975
• Device Lot Number: 5299905
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/21/2021
• Patient Sequence Number: 1