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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
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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22608
Medical Device Problem Code Defective Alarm (1014)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver had intermittent audio output.It was reported that, an adult patient was using a pediatric receiver.Labeling indicates: the dexcom g4 platinum (pediatric) continuous glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes.No product was provided for evaluation.The complaint confirmation of the receiver having intermittent audio output could not be determined.A probable cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
MDR Report Key7866556
Report Number3004753838-2018-106160
Device Sequence Number2013134
Product Code MDS
UDI-Device Identifier10386270000184
UDI-Public10386270000184
Combination Product (Y/N)N
Initial Reporter StateCT
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) 08/17/2018
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 NumberMT22608
Device Catalogue NumberSTK-PR-001
Device Lot Number5206620
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 08/17/2018
Initial Report FDA Received Date09/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age18 YR
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