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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 MT20649-1
Device Problem Defective Alarm (1014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver had intermediate audio output.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of no audio output could not be determined.A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).Describe event or problem - correction "dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver had intermediate audio output.The complaint confirmation of no audio output could not be determined.".
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver had intermittent audio output.The complaint confirmation of intermittent audio output 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 drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key8192299
MDR Text Key131322302
Report Number3004753838-2018-160586
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 11/28/2018
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
Device Operator Lay User/Patient
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5219224
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received01/16/2019
Supplement Dates FDA Received02/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2016
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 Age61 YR
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