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

Lot Number	UNKNOWN
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's mother stated that while sleeping at night, the tubing detached at the clip.She also reported that there was no damage to the tubing or the clip.The patient's blood glucose level was in high 300's mg/dl and had moderate level of ketones.Reportedly, the patient experienced nausea, vomiting and abdominal pain but remained on the pump.No further information available.

• Brand Name: INSET¿
• Common Device Name: INSET I 60/9 GREEN
• MDR Report Key: 8269722
• Report Number: 3003442380-2019-00260
• Device Sequence Number: 1557188
• Product Code: FPA
• UDI-Device Identifier: 05705244006928
• UDI-Public: 05705244006928
• 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: 09/26/2017
• Initial Report FDA Received Date: 01/23/2019
• Patient Sequence Number: 1