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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

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Patient Problems Discomfort (2330); Foreign Body In Patient (2687)
Event Date 07/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016 that the patient experienced a detached sensor wire on (b)(6) 2016. The sensor was inserted into the arm on (b)(6) 2016. Patient's mother reported that upon removal of the sensor pod, she did not see the sensor wire. The patient was brought to the hospital for an ultrasound, which confirmed that the sensor wire was retained within 1 centimeter of skin surface in subcutaneous fat and above muscle. It was indicated that there was a plan to surgically remove the sensor wire as it was causing discomfort. The patient has hypersensitivity to metal and patient's parent believes this is what is causing the discomfort in the site of the retained wire. No further event information is available. The sensor applicator was provided for evaluation. However, an investigation could not be performed due to no sensor/sensor wire being returned. Additionally, a copy of the ultrasound was not provided to dexcom. The reported event of detached sensor wire could not be confirmed. A root cause could not be determined. The sensor was inserted into the arm. Labeling indicates: do not insert the sensor component of the dexcom g5 mobile 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 g5 mobile system is not approved for other sites. If placed in other areas, the dexcom g5 mobile system may not function properly.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS 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 Key5892634
MDR Text Key52607813
Report Number3004753838-2016-80040
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,Followup
Report Date 07/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2016
Was Device Evaluated by Manufacturer? No
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: 08/21/2016 Patient Sequence Number: 1
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