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

Lot Number	5264711
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4) event occurred in the united states.It was reported that on (b)(6) 2019, the patient's infusion set's tubing came away from the set, as it detached from the site location, while sleeping on the chair.Her blood glucose was reported to be approximately above 300 mg/dl and she self-treated it by 9 units of insulin with the pump.The infusion was changed on (b)(6) 2019 and they were stored in a dresser.Reportedly, on (b)(6) 2019 (at the time of this report), this issue occurred again.As the patient woke up, she did not feel good and her blood glucose level was reported to be 450 mg/dl.The infusion had been in use for three days.The site location was on left side of her tummy and the pump was on the right side.The patient was unsure of any stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.At the time of this report ((b)(6) 2019), her blood glucose was 462 mg/dl at 06:40 am and blood glucose level was going down to 401 mg/dl at 07:43 am.No further information available.
Event or Problem Description
On (b)(6) -2019: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that all the test result 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 on (b)(6) 2019, the patient's infusion set's tubing came away from the set, as it detached from the site location, while sleeping on the chair.Her blood glucose was reported to be approximately above 300 mg/dl and she self-treated it by 9 units of insulin with the pump.The infusion was changed on (b)(6) 2019 and they were stored in a dresser.Reportedly, on (b)(6) 2019 (at the time of this report), this issue occurred again.As the patient woke up, she did not feel good and her blood glucose level was reported to be 450 mg/dl.The infusion had been in use for three days.The site location was on left side of her tummy and the pump was on the right side.The patient was unsure of any stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.At the time of this report ((b)(6) 2019), her blood glucose was 462 mg/dl at 06:40 am and blood glucose level was going down to 401 mg/dl at 07:43 am.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC GREY
• MDR Report Key: 9160615
• Report Number: 3003442380-2019-01825
• Device Sequence Number: 1924196
• Product Code: FPA
• UDI-Device Identifier: 05705244007796
• UDI-Public: 05705244007796
• 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: 12/01/2021
• Device Lot Number: 5264711
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/27/2019
• Patient Sequence Number: 1