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

Lot Number	5191364
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 he had an issue with faulty infusion sets for 2/3 days and removed the infusion from the site since then.Reportedly, the tubing detached from the cannula portion of his infusion set at quick release.The patient had this issue sometimes prior to insertion and sometimes when he had rise in blood glucose level.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC GREY
• MDR Report Key: 8283946
• Report Number: 3003442380-2019-00351
• Device Sequence Number: 1911635
• 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

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: 05/01/2020
• Device Lot Number: 5191364
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 01/28/2019
• Patient Sequence Number: 1