MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT 60/17 PCC

Lot Number	5175686
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported about a crack in the tubing.Reportedly, location of the leak was at tubing, however, the tubing did not detach but cracked and it was about 6 inches from where the connector fits to the reservoir.The patient stated that pump was not dropped with set in place.The patient had blood glucose values of 600 mg/dl at time of incident.The patient took 5 units of manual injections to treat high blood glucose levels.The patient was neither in the emergency room, nor in the hospital at the time of this report.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT 60/17 PCC
• MDR Report Key: 8324844
• Report Number: 8021545-2019-00110
• Device Sequence Number: 14010373
• Product Code: FPA
• UDI-Device Identifier: 05705244008755
• UDI-Public: 05705244008755
• 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: 12/01/2019
• Device Lot Number: 5175686
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 02/11/2019
• Patient Sequence Number: 1