MAUDE Adverse Event Report: AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US

Model Number 1003912

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 a (b)(6)-year old male child patient experienced high blood glucose levels due to a bent cannula. At the time of the event, his blood glucose level was 574 mg/dl which he tried to treat with a correction bolus via the pump. Subsequently, on (b)(6) 2021, he was admitted to the emergency room, was then transferred to pediatric intensive care unit in ambulance and was consequently hospitalized. He had high ketones, which his health care professional assessed as dangerous/ life threatening. During his stay, he was administered fluids of saline, insulin and intravenously some unspecified medication (drug name unknown) as corrective treatment which resolved the issue. On (b)(6) 2021, he was released from the hospital with no permanent damage. This issue occurred with one infusion set and it was used a little more than 12 hours. Further, there was no damage to the infusion sets when the package was first opened. Reportedly, they replaced the infusion set and resumed insulin 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 80/6 GREY TCAP 10PACK US
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12126426
• MDR Text Key: 260226349
• Report Number: 3003442380-2021-00313
• Device Sequence Number: 1
• Product Code: FPA
• 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

0 Patients were Involved in the Event:

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1003912
• Device Lot Number: 5320812
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage