MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/9 GREY TCAP 10PK INT

Model Number 1001681

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 did not feel good due to her high blood glucose level (554 mg/dl) because she assumed her pump did not gave her insulin to bring blood glucose level down, so they tried to treat this via the pump.Her health care professional recommended her go to the emergency room, due to a high blood glucose level of 400-500 mg/dl.Subsequently, on (b)(6) 2021, she was admitted to the hospital due to high blood glucose level which were due to a bent cannula which was observed when the cannula was removed in the hospital.During hospitalization she was administered fluids of saline, insulin and some unspecified medication (drug name unknown) intravenously which did not resolve the issue.Moreover, she had a heart attack during her stay as a permanent damage.Moreover, there was no damage when the infusion set package was first opened.Reportedly, the infusion set was replaced, and insulin was resumed successfully.On (b)(6) 2021, she was released from the hospital.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 60/9 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 11662645
• MDR Text Key: 245516820
• Report Number: 3003442380-2021-00214
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016651
• UDI-Public: 05705244016651
• 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: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1001681
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/02/2021
• Type of Device Usage: N
• Patient Sequence Number: 1