MAUDE Adverse Event Report: MINIMED MIO; MIO 80/6 SC1 GREY

Lot Number	UNKNOWN
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.It was reported that patient's infusion set's tubing was falling off and it came apart at the infusion site while she was sleeping, as the tubing was too short.The site location was her leg and the pump was located in the right arm on her shirt.Moreover, the infusion had been used for 18 hours.The infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently ((b)(6) 2020), her blood glucose level was 237 mg/dl.No further information available.
Event or Problem Description
On 24-nov-2020: 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.Based on the result: type of investigation code, investigation findings code and investigation conclusions code codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.It was reported that patient's infusion set's tubing was falling off and it came apart at the infusion site while she was sleeping, as the tubing was too short.The site location was her leg and the pump was located in the right arm on her shirt.Moreover, the infusion had been used for 18 hours.The infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently ((b)(6) 2020), her blood glucose level was 237 mg/dl.No further information available.

• Brand Name: MINIMED MIO
• Common Device Name: MIO 80/6 SC1 GREY
• MDR Report Key: 10578878
• Report Number: 3003442380-2020-00395
• Device Sequence Number: 10838896
• Product Code: FPA
• UDI-Device Identifier: 05705244020153
• UDI-Public: 05705244020153
• 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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1