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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 Break (1069); Use of Device Problem (1670)
Patient Problems Unspecified Infection (1930); Swelling (2091); Foreign Body In Patient (2687)
Event Date 11/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, of a broken sensor wire. The sensor was inserted at the forearm on (b)(6) 2016. Patient nurse reported that the patient visited their office on (b)(6) 2016 complaining of an infection from a retained sensor wire. The insertion site was described as tender and swelling. An ultrasound exam was performed. The nurse reported that patient was started on antibiotics and an appointment was scheduled with a surgeon for the sensor wire removal. The name of the antibiotics is not known. At the time of contact, patient is recovering. No product or data were provided for evaluation. The reported broken sensor wire could not be confirmed. A root cause could not be determined. The sensor was inserted into the forearm. Labeling indicates: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks. Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A sensor (serial number (b)(4) and lot number 5218520) was returned for evaluation. A visual inspection was performed and the sensor wire was missing from the sensor pod and housing puck. The reported event of a broken sensor wire was not confirmed because the wire was not present. A root cause could not be determined.
 
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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 Key6172363
MDR Text Key62311515
Report Number3004753838-2016-88441
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2017
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: 12/13/2016 Patient Sequence Number: 1
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