MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC PINK

Lot Number	5267072
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing came out from the quick release while she was sleeping at night.Reportedly, the actual release remained attached to the site, but the tubing fell out.When she woke up, her blood glucose level was 146 mg/dl, although she had been running a lot lower.Thereafter, she reached out to her trainer who informed her to take it off.The site location was upper thigh and the pump was on the same side as the site located on her waistband.The infusion was used for less than 4 hours and they were stored on the desk in her guest room.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 08-nov-2019: 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.Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing came out from the quick release while she was sleeping at night.Reportedly, the actual release remained attached to the site, but the tubing fell out.When she woke up, her blood glucose level was 146 mg/dl, although she had been running a lot lower.Thereafter, she reached out to her trainer who informed her to take it off.The site location was upper thigh and the pump was on the same side as the site located on her waistband.The infusion was used for less than 4 hours and they were stored on the desk in her guest room.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 60/6 PCC PINK
• MDR Report Key: 8919419
• Report Number: 3003442380-2019-01701
• Device Sequence Number: 2548728
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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: 01/01/2022
• Device Lot Number: 5267072
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 11/08/2019
• Patient Sequence Number: 1