MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

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 on (b)(6) 2022, the patient faced a bent cannula, and the symptoms/issue were noticed within three hours of insertion.He experienced high blood glucose level due to a bent cannula, which they tried to treat with a bolus via the pump.At the time of the event, his blood glucose level was 600-669 mg/dl.The infusion set had been used for three days.Consequently, he went to the emergency room, as his highest blood glucose level was reported to be more than 400-459 mg/dl.Moreover, he had high ketones which his health care professional assessed as dangerous/ life threatening and was subsequently admitted in the intensive care unit due to diabetic ketoacidosis.He stayed in the emergency room for one week and was administered humalog injections, levemir long-acting insulin injections as corrective treatment which resolved the issue.On (b)(6) 2022, he was released from the hospital with no permanent damage.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 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14012344
• MDR Text Key: 288584008
• Report Number: 3003442380-2022-00505
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002817
• Device Lot Number: 5359631
• Date Manufacturer Received: 03/22/2022
• Patient Sequence Number: 1