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

Model Number 1002821

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).The patient's mother reported that on (b)(6) 2021, at 07:30 pm, they changed the infusion set and cartridge, but the patient's blood glucose level started rising.Therefore, the patient experienced diabetic ketoacidosis due to high blood glucose values (about 400 mg/dl).The mother called the health care professional and she was assisted in managing the high blood glucose values.The health care professional suggested to change the infusion set and to deliver correction bolus by multiple daily injection.On (b)(6) 2021, at 03:00 am, after the infusion set was removed, they noticed that the cannula was bent.Again at 08:30 am, when the infusion set was changed, the cannula was bent.The patient had vomit during the high blood glucose event, so she received a vial of ondansetron.At 11:30 am, they changed the infusion set and again faced a bent cannula.This issue occurred with three subsequent infusion sets.The fourth infusion set had no problems and the blood glucose level of the patient started decreasing.In the afternoon of (b)(6) 2021, the patient's blood glucose level was stabilized and since then the patient has been in good condition.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 PINK TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12216570
• MDR Text Key: 263097492
• Report Number: 3003442380-2021-00332
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018242
• UDI-Public: 05705244018242
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2023
• Device Model Number: 1002821
• Device Lot Number: 5320752
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 07/23/2021
• Type of Device Usage: N
• Patient Sequence Number: 1