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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); Component Missing (2306)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 02/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017 the sensor wire was missing.The attempted sensor insertion was at the leg.Reportedly, the patient removed the transmitter prior to removing the sensor pod.No additional event or patient information is available.No product or data were provided for evaluation.The reported missing sensor wire could not be confirmed.A root cause could not be determined.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.Labeling indicates: do not remove the transmitter before removing the sensor pod from your body.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Subsequent to the initial mdr, dexcom received additional information on 03/15/2017 regarding an adverse event.The patient contacted their physician on (b)(6) 2017 and stated that they inserted the sensor into their thigh.It was reported that the sensor did not start up nor function.The patient did not visualize the sensor wire at the skin side of the sensor pod when they removed the sensor pod from their thigh.The patient believes that the sensor wire is retained because when they touch their thigh in the area where the sensor was worn, they could feel something under their skin.At the time of contact with their physician, the patient did not report any signs or symptoms of inflammation or infection.There were no x-rays taken and no treatment was provided as the patient was not seen by their physician.No additional event or patient information is available.
 
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Brand Name
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key6399398
MDR Text Key69851371
Report Number3004753838-2017-21272
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 Other
Type of Report Initial,Followup
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/15/2017
Initial Date FDA Received03/13/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/29/2017
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
Patient Weight83
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