MAUDE Adverse Event Report: INSET¿II; INSET II 60/6 BLUE

Lot Number	5167015
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the patient was hospitalized for high blood glucose level (600 mg/dl).The patient had symptoms including nausea, vomiting, ketones present, unsteadiness when standing or walking, severe dizziness, light-headedness, severe headache, extreme thirst, excess urination, symptoms of dehydration, rapid deep breathing, shortness of breath, abdominal pain and chest pain.During hospitalization, the patient received fluids via intravenous route and insulin injection.In the hospital, the pump and the infusion set were taken away.The health care profession had noticed that the insertion site was wet and the infusion set had a bent cannula.Two days later, the patient restarted using pump but remained in the hospital.Until that day, the healthcare profession delivered insulin with pen and intravenous fluid.Patient's blood glucose level was 98 mg/dl.Four days after hospitalization, the patient was still in the hospital with decreased blood glucose level.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: INSET¿II
• Common Device Name: INSET II 60/6 BLUE
• MDR Report Key: 8538571
• Report Number: 3003442380-2019-01377
• Device Sequence Number: 11373632
• Product Code: FPA
• UDI-Device Identifier: 05705244007413
• UDI-Public: 05705244007413
• 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 Expiration Date: 11/01/2019
• Device Lot Number: 5167015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1