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

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

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) 2024, the patient received multiple site occlusion alarms and experienced high blood glucose level, sores in the mouth from vomiting.Therefore, they tried to treat it with correction bolus via pump and multiple daily injection, but she was hospitalized due to diabetic ketoacidosis.Her highest blood glucose level was 800 mg/dl and had high ketones which the healthcare professional assessed as dangerous or life-threatening.Moreover, the issue occurred with one infusion set used for approximately for four hours and site location was stomach, had tried legs and back.Further, the patient was hospitalized for two days.No further information was 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: 19017997
• MDR Text Key: 339083043
• Report Number: 3003442380-2024-00213
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• Combination Product (y/n): N
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/28/2024
• Patient Sequence Number: 1