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

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

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's cannula broke inside their body (infusion set was replaced on (b)(6)2024) which led to high blood glucose level.They tried to treat it with bolus via pump but on (b)(6)2024, the patient first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Further, she had diabetic ketoacidosis.Her highest blood glucose level was 693 mg/dl and ketone level were high which the healthcare professional assessed as dangerous or life-threatening.During hospitalization, the patient received fluids of saline (unknown), insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.No further information was available.

• Brand Name: AUTOSOFT XC
• Type of Device: UNO INSET I 60/6 PINK TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19103479
• MDR Text Key: 340106640
• Report Number: 3003442380-2024-00221
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016682
• UDI-Public: 05705244016682
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/04/2024
• Patient Sequence Number: 1