MAUDE Adverse Event Report: MIO; INSET II 80/6 PCC PINK

Model Number	MMT-925
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the infusion set's tubing was detached from patient's body at the site location while sleeping and her blood glucose level went high to 350 mg/dl.The site location was patient's back and the pump was in her bed.Moreover, the infusion set was used for not less than 24 hours.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Reportedly, her current (new) infusion set was working fine so far.No further information available.
Event or Problem Description
On 04-sep-2020: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that the tubing was detached from the tubing connector (missing glue).Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the infusion set's tubing was detached from patient's body at the site location while sleeping and her blood glucose level went high to 350 mg/dl.The site location was patient's back and the pump was in her bed.Moreover, the infusion set was used for not less than 24 hours.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Reportedly, her current (new) infusion set was working fine so far.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 80/6 PCC PINK
• MDR Report Key: 10090601
• Report Number: 3003442380-2020-00276
• Device Sequence Number: 3540660
• Product Code: FPA
• UDI-Device Identifier: 05705244007871
• UDI-Public: 05705244007871
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 11/01/2022
• Device Model Number: MMT-925
• Device Lot Number: 5301424
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 09/07/2020
• Patient Sequence Number: 1