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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-PNK
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver display was frozen.No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of the frozen display was undetermined.The probable cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7253154
MDR Text Key99800934
Report Number3004753838-2018-014145
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000160
UDI-Public10386270000160
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT22495-PNK
Device Catalogue NumberSTK-DR-PNK
Device Lot Number5198509
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age35 YR
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