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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 MT22495
Medical Device Problem Code Unable to Obtain Readings (1516)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/01/2018
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 an err 67 occurred on the receiver.It was reported that a pediatric patient was using an adult receiver.No additional event or patient information is available.No product or data was provided for evaluation.Confirmation of the complaint could not be determined.The root cause could not be determined.Labeling indicates: the dexcom system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes.
 
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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 drive
san diego 92121
MDR Report Key8201567
Report Number3004753838-2018-163297
Device Sequence Number2190197
Product Code MDS
UDI-Device Identifier20386270000150
UDI-Public20386270000150
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/01/2018
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 NumberMT22495
Device Catalogue NumberSTK-RR-001
Device Lot Number5209682
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/01/2018
Initial Report FDA Received Date12/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age7 YR
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