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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/21/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, the patient experienced a detached sensor wire. The sensor was inserted into the arm on (b)(6) 2016. Patient's father stated that a small part of the sensor wire was sticking out of the skin upon sensor pod removal. On (b)(6) 2016, the patient was seen by their doctor and x-rays were taken. X-rays did not display the sensor wire under the patient's skin. At the time of contact, the patient was doing well. Additional event or patient information was not provided. No product or data was returned for investigation. The reported 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 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 was returned for evaluation. A visual inspection was performed and found that the wire is missing from the sensor pod and housing puck. Due to the missing sensor wire, the sensor wire is considered detached. The customer's complaint of a missing/detached sensor wire was confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key5958325
MDR Text Key54990578
Report Number3004753838-2016-80196
Device Sequence Number1
Product Code MDS
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 08/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/02/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5209486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2016
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: 09/16/2016 Patient Sequence Number: 1
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