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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 Problem Abscess (1690)
Event Date 01/03/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 03/17/2017, that on (b)(6) 2017, the patient developed an abscess after removing the sensor. The patient's mother stated that she had noticed the abscess on the patient on (b)(6) 2017, after removing a sensor. The patient's mother took the patient to the emergency room (er). At the er there was an attempted to lance the abscess to drain it, but it did not drain. The er then prescribed an antibiotic. The patient and the patient's mother were told to wait a few days, and contact the patient's pediatrician if it did not get better. The patient's mother stated that she had taken the patient to see the pediatrician on (b)(6) 2017, and was prescribed another antibiotic cefdinir. The patient remained on this antibiotic for about 2 weeks. No further intervention was sought out after that. The patient's mother stated the location of the abscess was not usable for sensor insertions for about 5-6 weeks. At time of contact the patient's condition was still has a bump at abscess location, but was not painful. 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.
 
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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 Key6488926
MDR Text Key72653698
Report Number3004753838-2017-26291
Device Sequence Number1
Product Code MDS
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 03/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
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
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 Received03/17/2017
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: 04/13/2017 Patient Sequence Number: 1
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