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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT SHORT 60/13 SC1 MIN
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SILHOUETTE PARADIGM; UNO COMFORT SHORT 60/13 SC1 MIN Back to Search Results
Model Number MMT-381A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hyperglycemia (1905)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that at the middle of the night while sleeping, the patient's infusion set's tubing came off at the quick release/site connector.Therefore, her blood glucose level was 388 mg/dl at the time of the event.She did not get insulin over the night and it was a perfect tear.Previously, over the weekend she also faced the same issue, and her blood glucose level was 370 mg/dl.The site location was patient's arm and the pump was clipped on her waist.Moreover, the infusion had been used for the first day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, her blood glucose level was 360 mg/dl.No further information available.
 
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Brand Name
SILHOUETTE PARADIGM
Type of Device
UNO COMFORT SHORT 60/13 SC1 MIN
MDR Report Key12678395
MDR Text Key277888590
Report Number8021545-2021-00161
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244019584
UDI-Public05705244019584
Combination Product (y/n)Y
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/01/2024
Device Model NumberMMT-381A
Device Lot Number5350765
Date Manufacturer Received10/14/2021
Type of Device Usage N
Patient Sequence Number1
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