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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Model Number 9500-27
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Reaction (2414)
Event Date 12/02/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf. Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e. G. ,redness, swelling, bruising, itching, scarring or skin discoloration).
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2016, the patient experienced a skin reaction. The sensor was inserted into the abdomen on (b)(6) 2016. The reaction was located on the underneath the adhesive and was described as red, slightly swollen and hurting. The patient stated that the reactions to insertion sites have been occurring long before the dexcom system and that she has not discussed the dexcom system specifically with her doctor until (b)(6) 2017. On (b)(6) 2017 the patient told her doctor that the reactions are much better than they were with other systems. The doctor is not sure why the patient is having reactions. The patient stated that the doctor recommended an insertion sites other than the abdomen. The doctor did not make any other recommendations at that time. At the time of contact, the patient was well. No additional event or patient information was provided.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS 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 Key6386376
MDR Text Key69323190
Report Number3004753838-2017-15880
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)NI(17)NI
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
Type of Report Initial
Report Date 02/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/07/2017 Patient Sequence Number: 1
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