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

Model Number	MMT-378
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.It was reported that patient's infusion set's plastic tubing totally detached from the needle at the tubing connector during an outdoor event-working and he had no idea why it detached.Patient's blood glucose level was 300 mg/dl the site location was his abdomen and the pump was located right under his clothes and the set is 5-6 inches near to pump.Moreover, the infusion had been used for the second day.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: COMFORT 60/17 PCC
• MDR Report Key: 10498520
• Report Number: 8021545-2020-00115
• Device Sequence Number: 436430
• 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 Model Number: MMT-378
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/07/2020
• Patient Sequence Number: 1