MAUDE Adverse Event Report: AUTOSOFT 30; INSET 30 60/13 GREY TCAP

Lot Number	5231159
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the tubing snapped from where it was attached to the site from one infusion set.At the time of this event, blood glucose level was at 174 mg/dl.There was no damage noticed when the package was first opened.The infusion set will be replaced.No further information available.

• Brand Name: AUTOSOFT 30
• Common Device Name: INSET 30 60/13 GREY TCAP
• MDR Report Key: 8314112
• Report Number: 3003442380-2019-00450
• Device Sequence Number: 1589687
• Product Code: FPA
• UDI-Device Identifier: 05705244014602
• UDI-Public: 05705244014602
• Combination Product (Y/N): N
• PMA/510(K) Number: K061374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/01/2021
• Device Lot Number: 5231159
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 02/07/2019
• Patient Sequence Number: 1