MAUDE Adverse Event Report: INSET¿; INSET I 60/9 GREY

Lot Number	5136639
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 stated that on a few instances (including today) she did not saw drops come out of the tubing, so she had to use a new infusion set.She also said a couple of time, the tubing became detached from the cannula housing during the load process and she had to use new sets.Reportedly, at the time of this event, she saw insulin migrate through the line during the fill tubing step, but no drops ever came out and she also saw some air bubbles.The blood glucose was 136 mg/dl at the time of this event.The patient did not notice any damage when the package was first opened.Moreover, the patient did not do the air removal step as per protocol when preparing the cartridge.No further information available.

• Brand Name: INSET¿
• Common Device Name: INSET I 60/9 GREY
• MDR Report Key: 8423578
• Report Number: 3003442380-2019-00599
• Device Sequence Number: 1795664
• Product Code: FPA
• UDI-Device Identifier: 05705244006881
• UDI-Public: 05705244006881
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• 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: 07/01/2019
• Device Lot Number: 5136639
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 03/15/2019
• Patient Sequence Number: 1