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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 Pain (1994); 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 thigh on (b)(6) 2016. Patient indicated that upon removal of the sensor pod, the sensor wire was not visible on the skin-side of the sensor pod nor was a portion of the wire exposed on the surface of the skin. Sensor wire was also not visible through the skin. Patient stated that they had been experiencing pain upon muscle movement and exercise but had no pain while being still. Patient reported that on (b)(6) 2016 he was going to the urgent care to seek medical attention. Patient had an x-ray taken, which confirmed the presence of the retained sensor wire. The patient was advised not to remove the wire and to monitor the situation instead. No additional event or patient information was provided. No product was returned for investigation. A copy of the x-ray was not provided for evaluation. The reported event of retained sensor wire could not be confirmed. A root cause could not be determined. The sensor was inserted into the thigh. 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.
 
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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 Key5892644
MDR Text Key52608361
Report Number3004753838-2016-80037
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 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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2016
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: 08/21/2016 Patient Sequence Number: 1
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