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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT 60/17 PCC
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SILHOUETTE® PARADIGM®; COMFORT 60/17 PCC Back to Search Results
Lot Number UNKNOWN
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.The patient reported that the infusion set's tubing had detached from the tubing connector, while performing normal daily activity/no extracurricular.The site location was around the patient's hips and the pump was located on the belt.This issue happened for the first time.Reportedly, the blood glucose level at the time of incident was 400 mg/dl but the patient felt fine.The infusions were stored in the bedroom.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.
 
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Brand Name
SILHOUETTE® PARADIGM®
Common Device Name
COMFORT 60/17 PCC
MDR Report Key9374557
Report Number8021545-2019-00146
Device Sequence Number16680821
Product Code FPA
UDI-Device Identifier05705244008755
UDI-Public05705244008755
Combination Product (Y/N)N
PMA/510(K) Number
K162812
Number of Events Summarized1
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 Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/01/2019
Initial Report FDA Received Date11/26/2019
Patient Sequence Number1
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