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

Lot Number	5198590
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that 3 days prior to the day of report (dated (b)(6) 2018), in the morning her son's infusion set was changed before school.Further, she stated that her son's infusion set's tubing had detached, while she was unwinding the tubing.Moreover, the patient had lot of pain during insertion.Reportedly, his blood glucose was high around lunch time.Upon visual inspection, of returned used devices (1 set / 1 serter), it was found that the set was detached from the tubing connector and a drop of glue was found on tubing connector.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 9294495
• Report Number: 3003442380-2019-01911
• Device Sequence Number: 390222
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• 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: 09/01/2020
• Device Lot Number: 5198590
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 11/08/2019
• Patient Sequence Number: 1