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

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.On (b)(6) 2021, it was reported that while the patient was watching television, he noticed that the infusion set had detached from the tubing connector while sleeping.The site location was patient's abdomen and the pump was on the left side in relation to the site.Moreover, the infusion had been used for one day.Reportedly, the infusions were stored in the bathroom and had a little of humidity.There was no stress of pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, his blood glucose level was 320 mg/dl.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: UNO COMFORT 60/17 PCC MINI
• MDR Report Key: 11795790
• Report Number: 8021545-2021-00114
• Device Sequence Number: 3973132
• Product Code: FPA
• UDI-Device Identifier: 05705244008755
• UDI-Public: 05705244008755
• Combination Product (Y/N): Y
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 05/03/2021
• Initial Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1