MAUDE Adverse Event Report: MIO; INSET II 60/6 PCC BLUE

Model Number	MMT-943
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) 2020, it was reported by the patient that when she opened the package of her infusion set, it was noticed that the tubing was detached from set at the tubing connector.Further, it was found that the other tubing was not attached to set when she opened it.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Also, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, her blood glucose level was 140 mg/dl.No further information available.
Event or Problem Description
On 16-mar-2021: follow up information was submitted to update health effect - impact code and component code.Moreover, the result of the complaint investigation (visual inspection) of the returned used device (1 set) showed that the tubing was detached from the tubing-tubing connector (missing glue).Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, it was reported by the patient that when she opened the package of her infusion set, it was noticed that the tubing was detached from set at the tubing connector.Further, it was found that the other tubing was not attached to set when she opened it.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Also, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, her blood glucose level was 140 mg/dl.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 10654991
• Report Number: 3003442380-2020-00418
• Device Sequence Number: 16948782
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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,Followup

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: 02/01/2023
• Device Model Number: MMT-943
• Device Lot Number: 5311069
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1