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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-PNK
Medical Device Problem Code Defective Alarm (1014)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/07/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted: (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.No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of 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 Key7393619
Report Number3004753838-2018-034357
Device Sequence Number1095205
Product Code MDS
UDI-Device Identifier30386270000195
UDI-Public30386270000195
Combination Product (Y/N)N
Initial Reporter StateTX
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) 03/12/2018
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-PNK
Device Catalogue NumberSTR-PR-PNK
Device Lot Number5230568
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2018
Initial Report FDA Received Date04/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age4 YR
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