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

Lot Number	UNKNOWN
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 (b)(6).The patient reported that when the tubing connects to the connector part it goes wrong each time.In the morning of the day of this report, she was high as well because the tubing came off again, and she already changed her whole infusion set.Patient's blood glucose level at the time of incident was 26 mmol/l and had symptoms related to high blood glucose level.The infusion was last changed 2 days ago, and no leakage was observed except in the detached part.Currently, her blood glucose level was 26 mmol/l.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 8342469
• Report Number: 3003442380-2019-00567
• Device Sequence Number: 11243543
• Product Code: FPA
• UDI-Device Identifier: 05705244007338
• UDI-Public: 05705244007338
• 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

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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 02/15/2019
• Patient Sequence Number: 1