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

Lot Number	5147521
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported that the infusion set tubing broke approximately 4 inches from the luer-lock connection.The patient also stated that the tubing appeared to have been cut.The patient had high blood glucose level reported to be over 240 mg/dl, which was treated with a manual injection of insulin.The patient also had high level of ketones.The patient did not notice any damage when the package was first opened.The patient was able to successfully apply a new infusion set to the customer and resume insulin on the pump.No further information available.

• Brand Name: INSET¿
• Common Device Name: INSET I 60/9 GREY
• MDR Report Key: 8463046
• Report Number: 3003442380-2019-00729
• Device Sequence Number: 16479139
• 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: 5147521
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1