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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4)0 event occurred in the united states.It was reported that the patient was sleeping and woke up, the infusion set's tubing already disconnected at the quick release.The site location was right side of patient's abdomen and the pump was located on the right side.Moreover, the infusion had been used for the first day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.
Event or Problem Description
On 21-sep-2020: follow up information was submitted to update health effect - clinical code and health effect - impact code.Moreover, the result of complaint investigation of the returned used device (1 tubing) showed that the tubing was detached from the tubing connector (missing glue).Based on the result: component, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number 1374055.Event occurred in the united states.It was reported that the patient was sleeping and woke up, the infusion set's tubing already disconnected at the quick release.The site location was right side of patient's abdomen and the pump was located on the right side.Moreover, the infusion had been used for the first day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 10108640
• Report Number: 3003442380-2020-00286
• Device Sequence Number: 3448423
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• Combination Product (Y/N): N
• 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 Model Number: MMT-943
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1