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

Model Number 1003912

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states it was reported that in last month, an eleven-year-old patient's infusion set's tubing detached/broken at site connector.At the time of the event, her blood glucose level was in the range of 130-260 mg/dl.Moreover, they replaced the infusion set, cartridge and resumed insulin successfully.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: 15119594
• MDR Text Key: 303926416
• Report Number: 3003442380-2022-00899
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244021099
• UDI-Public: 05705244021099
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1003912
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/19/2022
• Patient Sequence Number: 1