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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 MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problem Detachment Of Device Component (1104)
Patient Problems Increased Sensitivity (2065); Foreign Body In Patient (2687)
Event Date 05/17/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Second sensor wire (missing) mentioned is being reported under mfr 3004753838-2016-03451.
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report two (2) missing sensor wires that occurred on (b)(6) 2016. The patient's mother reported that both sensors were retained on the same day, one after another. The sensor was inserted into the abdomen on (b)(6) 2016. The patient mother reported patient was feeling tenderness at the insertion site. Patient's mother called endocrinologist who told her to take the patient to the primary care physician. On (b)(6) 2016, patient's mother took patient to the primary care physician. X-rays were taken and confirmed there was one (1) sensor in the body. They could not find the second sensor wire as patient was wearing a sensor on the other side of abdomen. The doctor referred the patient's mother to a pediatric surgeon. On (b)(6) 2016, patient's mother took patient to a pediatric surgeon for consultation. No procedures were performed. Patient's mother was told to monitor the site. No follow up visit was scheduled. At the time of contact, patient was in good condition. No further event or patient information is available.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4) describe event or problem - additional, if follow-up, what type?: additional information.
 
Event Description
A sensor pod was returned for evaluation. A visual inspection was performed and the sensor wire was missing from the sensor pod. The reported event of a missing sensor wire was confirmed; however, it is unknown if the returned device is the complaint device. A root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5724713
MDR Text Key47390707
Report Number3004753838-2016-03452
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)5205382(17)161111
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,Followup
Report Date 05/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5205382
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 Received08/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2015
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: 06/14/2016 Patient Sequence Number: 1
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