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

Model Number 1002819

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 the last two months, the patient's infusion set's tubing detached/broken at the site connector and this issue occurred with three infusion sets.Therefore, her blood glucose level was 353 at the time of the event.Moreover, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: UNO INSET II 60/9 GREY TCAP 10PK INT
• MDR Report Key: 12655135
• MDR Text Key: 277252870
• Report Number: 3003442380-2021-00582
• 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
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1002819
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/07/2021
• Type of Device Usage: N
• Patient Sequence Number: 1