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

Model Number 1002819

Device Problem Appropriate Term/Code Not Available (3191)

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 an infusion set issue (as believed by her physician) which they tried to treat with a bolus via the pump.The infusion set had been used for two hours.Subsequently, on (b)(6) 2022, she was taken to the emergency room with blood glucose level of 497 mg/dl and stayed there for six hours.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 there was no permanent damage.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: 14641177
• MDR Text Key: 293610365
• Report Number: 3003442380-2022-00747
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002819
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/09/2022
• Patient Sequence Number: 1