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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 Problems Use of Device Problem (1670); Component Missing (2306)
Patient Problems Erythema (1840); Pain (1994); Swelling (2091)
Event Date 02/24/2017
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) 2017, the sensor wire was missing in addition to an adverse event that occurred. The sensor was inserted in the patient's leg. The patient stated that on (b)(6) 2017 she started experience ding discomfort around the insertion area. The patient stated that the area was red, swollen with pain and a scab was present upon removing the sensor. The patient stated that she went to the hospital around 4am on (b)(6) 2017, because she did not see the sensor wire upon removing the sensor pod and thought it was still underneath the skin. At the hospital they performed an x-ray and sonogram and advised the patient that they did not see or find anything. No medication was giving and nothing else was done by the hospital. At time of contact the patient's condition was good. No additional event or patient information is available. No product was provided for evaluation. The reported event could not be confirmed. A root cause cannot be determined. Labeling indicates: do not insert the sensor component of the dexcom system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the dexcom system is not approved for other sites. If placed in other areas, the dexcom system may not function properly.
 
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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 Key6430643
MDR Text Key70736618
Report Number3004753838-2017-23379
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 02/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot NumberASKU
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 Received02/25/2017
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: 03/23/2017 Patient Sequence Number: 1
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