MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 2-PACK 60/6 GREY TCAP

Model Number 1000281

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that on (b)(6) 2021 and (b)(6) 2021, the patient's infusion set's tubing detached/broken at the site connector.Therefore, her blood glucose level was 200 mg/dl at the time of the event which they tried to treat with multiple daily injections.She had moderate ketone levels which were assessed not to be dangerous/life threatening.Moreover, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: INSET II 2-PACK 60/6 GREY TCAP
• MDR Report Key: 12655057
• MDR Text Key: 277208272
• Report Number: 3003442380-2021-00581
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014541
• UDI-Public: 05705244014541
• 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: 1000281
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/07/2021
• Type of Device Usage: N
• Patient Sequence Number: 1