MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT SHORT 110/13 PCC

Lot Number	5244059
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that while the patient went out to eat last evening and hung the infusion set on pocket like normally, the infusion set's tubing leaked from where the tubing connects to tubing connector.Reportedly, her mouth was really dry, and her blood glucose was 300 mg/dl at that point and she experienced mild diabetic ketoacidosis.She took an additional unit and the blood glucose went up to 400 mg/dl.Since her blood glucose did not went down and she did not saw any leak, so she disconnected the tubing from the body and put fill cannula through it to see whether insulin came through.However, no insulin came through, she tried few times and did not saw insulin but when she looked under the tubing it was wet had been leaking.Reportedly, she felt like she could see a compromise in the tubing at a spot.This issue happened earlier about a few weeks ago.The site location was right side, below the navel and the pump was on the left side, site was below the navel.The infusion was used for around 30 hours.The infusions were stored in a wardrobe.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT SHORT 110/13 PCC
• MDR Report Key: 8481420
• Report Number: 8021545-2019-00119
• Device Sequence Number: 16584748
• Product Code: FPA
• UDI-Device Identifier: 05705244009165
• UDI-Public: 05705244009165
• Combination Product (Y/N): N
• PMA/510(K) Number: K162812
• 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: 06/01/2021
• Device Lot Number: 5244059
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/04/2019
• Patient Sequence Number: 1