MAUDE Adverse Event Report: INSET¿; INSET I 60/6 GREY

Lot Number	UNKNOWN
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Event occurred in the united states.It was reported that the patient experienced a compromised infusion site.Reportedly, the blood glucose level was 380 mg/dl, which was self-treated with a correction using multiple daily injection.Subsequently, the patient was hospitalized and received intravenous insulin drip as corrective treatment which resolved the issue.The patient was admitted for three days and there was no permanent damage to the patient.The infusion set was used for one day.No further information available.

• Brand Name: INSET¿
• Common Device Name: INSET I 60/6 GREY
• MDR Report Key: 8517056
• Report Number: 3003442380-2019-01163
• Device Sequence Number: 1846419
• Product Code: FPA
• UDI-Device Identifier: 05705244006874
• UDI-Public: 05705244006874
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1