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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
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DEXCOM INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM Back to Search Results
Model Number MT22495-BLU
Medical Device Problem Code Device Inoperable (1663)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/25/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017 the receiver ceased to function.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the receiver ceasing to function could not be determined.A root cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM INC.
6340 sequence dr
san diego CA 92121
MDR Report Key7043307
Report Number3004753838-2017-46650
Device Sequence Number1345405
Product Code MDS
UDI-Device Identifier20386270000174
UDI-Public20386270000174
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/25/2017
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 Lay User/Patient
Device Model NumberMT22495-BLU
Device Catalogue NumberSTK-RR-BLU
Device Lot Number5222340
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/25/2017
Initial Report FDA Received Date11/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age62 YR
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