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

Lot Number	5211979
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
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient reported that her infusion set fell apart at night when she was sleeping.Reportedly, the tubing got separated from the clip at the quick-release and the clip itself was connected to the site.She woke up with blood glucose level of 18 mmol/l.She changed the infusion site and her blood glucose level dropped down to 9.3 mmol/l at the time of this report.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 8280536
• Report Number: 3003442380-2019-00335
• Device Sequence Number: 2463183
• Product Code: FPA
• UDI-Device Identifier: 05705244007710
• UDI-Public: 05705244007710
• 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 Expiration Date: 04/01/2021
• Device Lot Number: 5211979
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 01/28/2019
• Patient Sequence Number: 1