MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT 80/17 PCC

Lot Number	5284929
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported issues with the sites and when she finds a good site, it seemed like the insulin was not being absorbed.It was stated that she ate piece of toast as breakfast sandwich, 30 carbohydrates for lunch sandwich and 30 carbohydrates for dinner.She also mentioned that she did not had even a hefty meal a day before hospitalization.Subsequently, on (b)(6) 2019, she was admitted to the emergency room with blood glucose level was 659 mg/dl and with 18 units of insulin.During hospitalization, she received insulin drip and blood glucose was monitored hourly.The infusion was changed on (b)(6) 2019.During hospitalization, she removed the site and discovered that the cannula was bent but there was no alarm from the pump and her blood glucose level at that time were already normal.She was admitted for 2 and a half days.At the time of this report ((b)(6) 2019), her blood glucose level was 499 mg/dl with an active insulin of 7.4 units which increased to 561 mg/dl during the call.Further, she delivered 4 units of insulin after 15 minutes and her blood glucose was at 510 mg/dl.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT 80/17 PCC
• MDR Report Key: 9138429
• Report Number: 8021545-2019-00143
• Device Sequence Number: 3046760
• Product Code: FPA
• UDI-Device Identifier: 05705244009035
• UDI-Public: 05705244009035
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 06/01/2022
• Device Lot Number: 5284929
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1