MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number 1001680

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced high blood glucose levels and went into diabetic ketoacidosis due to a bent cannula.At the time of the event, his blood glucose level was 570 mg/dl or higher (exact value unknown), which the patient tried to treat with a correction injection via multiple daily injection.Consequently, on (b)(6) 2021, he went to the emergency room and stayed there for three hours.Subsequently, he was admitted to the hospital as he had high ketone levels which his healthcare professional assessed them as dangerous/ life threatening.During hospitalization, it was noticed that his infusion set's cannula was bent, and he was administered fluids of saline, insulin and an unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2021, the patient was released from the hospital with no permanent damage.Moreover, the infusion set had been used for 24 hours and there was no damage to the infusion sets when the package was first opened.This issue happened with one infusion set.Further, it was stated that he replaced the infusion set and insulin was resumed successfully.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: AUTOSOFT XC
• Type of Device: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 11955945
• MDR Text Key: 254929287
• Report Number: 3003442380-2021-00271
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2023
• Device Model Number: 1001680
• Device Lot Number: 5320824
• Date Manufacturer Received: 05/27/2021
• Type of Device Usage: N
• Patient Sequence Number: 1