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

Model Number	MMT-945
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that one of the infusion set's tubing was not connected to the needle.The site of insertion was the patient's abdomen and the blood glucose level was 219 mg/dl at the time of incident.No further information available.
Event or Problem Description
On 19-may-2020: follow up information was submitted because a visual inspection and test for static pull was performed of the returned used device (1 used set) and the result of complaint investigation showed that all test results were within specifications.Based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.It was reported that one of the infusion set's tubing was not connected to the needle.The site of insertion was the patient's abdomen and the blood glucose level was 219 mg/dl at the time of incident.No further information available.On 19-may-2020: follow up information was submitted because a visual inspection and test for static pull was performed of the returned used device (1 used set) and the result of complaint investigation showed that all test results were within specifications.Based on the result: device, method, result and conclusion codes were updated.

• Brand Name: MIO
• Common Device Name: INSET II 80/6 PCC BLUE
• MDR Report Key: 9449093
• Report Number: 3003442380-2019-01963
• Device Sequence Number: 19576348
• Product Code: FPA
• UDI-Device Identifier: 05705244007734
• UDI-Public: 05705244007734
• 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: 02/01/2022
• Device Model Number: MMT-945
• Device Lot Number: 5272022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 05/19/2020
• Patient Sequence Number: 1