MAUDE Adverse Event Report: INSET¿; INSET I 60/9 GREY

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 the tubing broke off from the connector piece of her infusion set which caused high blood glucose level of 524 mg/dl.Reportedly, she changed out the site and self-treated with a correction bolus with the pump.The patient did not notice any damage when the package was first opened.No further information available.

• Brand Name: INSET¿
• Common Device Name: INSET I 60/9 GREY
• MDR Report Key: 8467994
• Report Number: 3003442380-2019-00836
• Device Sequence Number: 1920328
• Product Code: FPA
• UDI-Device Identifier: 05705244006881
• UDI-Public: 05705244006881
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• 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: 05/31/2017
• Initial Report FDA Received Date: 03/31/2019
• Patient Sequence Number: 1