MAUDE Adverse Event Report: MIO; INSET II 46/6 PCC BLUE

Model Number	MMT-941
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 plastic in the needle came off while the patient was sleeping.The blood glucose level from (b)(6) 2019 to (b)(6) 2019, between 10:26 pm to 02:00 am was 316 mg/dl and from (b)(6) 2019 to (b)(6) 2019, between 10:38 am to 02:00 am was 314 mg/dl.The infusion set's tubing came apart close to the site location.The site location was on the top of the back side of patient and the pump was worn on the belt.The infusion had been used for about 3 days.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 the patient's body.No further information available.
Event or Problem Description
On 06-mar-2020: follow up information was submitted to update expiration date and result of complaint investigation of the returned used device (1 set) which showed that the tubing was detached from the tubing connector.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 plastic in the needle came off while the patient was sleeping.The blood glucose level from 28-oct-2019 to 31-oct-2019, between 10:26 pm to 02:00 am was 316 mg/dl and from 15-nov-2019 to 18-nov-2019, between 10:38 am to 02:00 am was 314 mg/dl.The infusion set's tubing came apart close to the site location.The site location was on the top of the back side of patient and the pump was worn on the belt.The infusion had been used for about 3 days.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 the patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 9442796
• Report Number: 3003442380-2019-01960
• Device Sequence Number: 2626463
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• 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: 10/01/2021
• Device Model Number: MMT-941
• Device Lot Number: 5259959
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/06/2020
• Patient Sequence Number: 1