MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/9 GREY TCAP 10PK INT

Model Number 1002819

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 due to a kink cannula (but was uncertain) which they tried to treat with a multiple daily injection.The infusion set had been used for three days.Subsequently, on (b)(6) 2022, she was taken to the emergency room with blood glucose level of 700 mg/dl and stayed there for four days.Further, her heart hormones went up acting like a heart attack.During hospitalization, she received fluids of saline, insulin, and an unspecified medication (drug name unknown) intravenously which resolved the issue.On (b)(6) 2022, she was released from the hospital and her heat issue got worse.Moreover, she reported a current high blood glucose event due to a kinked cannula, in which her blood glucose level was reported as 330-400 mg/dl which they tried to treat with a correction bolus via multiple daily injection and a bolus.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 60/9 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14641096
• MDR Text Key: 293614129
• Report Number: 3003442380-2022-00744
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018181
• UDI-Public: 05705244018181
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002819
• Device Lot Number: 5359551
• Date Manufacturer Received: 05/31/2022
• Patient Sequence Number: 1