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

Model Number	MMT-923
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).It was reported that when the patient woke up, the infusion set's tubing disconnected from the quick release section.She also stated that quick release clip was still attached to the secured cannula, but the tubing came away from that clip.Moreover, the patient did not feel it was pulled off or anything she just wanted to report it.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 10132092
• Report Number: 3003442380-2020-00294
• Device Sequence Number: 3220685
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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: 11/01/2022
• Device Model Number: MMT-923
• Device Lot Number: 5301130
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1