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

Lot Number	5254065
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).It was reported that the patient's infusion set's tubing had detached at the quick release, while the patient was uncoiling the tubing to insert.Reportedly, as he uncoiled the infusion set, it was noticed that it was not connected to the cannula and it was all sticky.The patient's serum glucose level was 13.9.The infusions were stored were stored in a closet in the bedroom, at a cool dry place, at room temperature.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon investigation of returned used device (1 set), it was found that the tubing was detached from the tubing connector (missing glue).No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC GREY
• MDR Report Key: 9236713
• Report Number: 3003442380-2019-01876
• Device Sequence Number: 16555578
• Product Code: FPA
• UDI-Device Identifier: 05705244007819
• UDI-Public: 05705244007819
• 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: 09/01/2021
• Device Lot Number: 5254065
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 10/25/2019
• Patient Sequence Number: 1