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

Lot Number	UNKNOWN
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 the united states.The patient reported that he had high blood glucose level of 378 mg/dl which he tried to treat with a bolus, but it did not bring it down.Further, he noticed that the infusion set's tubing was disconnected at the quick release, so he needed to replace his set and reservoir.At the time of the incident, his blood glucose level was 372 mg/dl.Upon investigation of the returned used device (1 set), it was found that the tubing was detached from the tubing connector (was not assembled properly).No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 9400144
• Report Number: 3003442380-2019-01943
• Device Sequence Number: 1672392
• 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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 12/03/2019
• Patient Sequence Number: 1