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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT 110/17 PCC
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SILHOUETTE® PARADIGM®; COMFORT 110/17 PCC Back to Search Results
Lot Number 5219443
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported that the tubing itself popped out of the clip (quick release) and was hanging there.The patient experienced high blood glucose level at the time.No further information available.
 
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Brand Name
SILHOUETTE® PARADIGM®
Common Device Name
COMFORT 110/17 PCC
MDR Report Key8485937
Report Number8021545-2019-00121
Device Sequence Number2758697
Product Code FPA
UDI-Device Identifier05705244009332
UDI-Public05705244009332
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 Number5219443
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2018
Initial Report FDA Received Date04/05/2019
Patient Sequence Number1
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