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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 DEXCOM SHARE SYSTEM MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS Back to Search Results
Model Number MT22495
Device Problem No Audible Alarm (1019)
Patient Problems Headache (1880); Confusion/ Disorientation (2553)
Event Date 05/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to reports no audio output from the receiver and an adverse event that occurred on (b)(6) 2016. Patient stated that on (b)(6) 2016 she was driving with her (b)(6) son, felt herself becoming disoriented with a headache and pulled the vehicle over. At some point patient grabbed her son's push up ice cream pop and ate it. Patient's husband called and walked her son through giving his mother juice. Patient also ate vanilla wafers and eventually started feeling better. No hospitalization was needed. Patient did not hear any alerts to warn her of the low at the time of event. At point of contact patient was feeling well. Additionally, patient's mother tested the receiver's alerts and they only vibrated. No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4) describe event or problem - additional, device available for evaluation - additional, additional information/device evaluation, device evaluated by manufacturer - additional, event problem and evaluation codes - additional.
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defects were found. A "try it" manual test was performed and speaker did not sound. The reported event of no audio output was confirmed. The root cause was determined to be a defective speaker.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defects were found. A "try it" manual test was performed and speaker did not sound. The reported event of no audio output was confirmed. The root cause was determined to be a defective speaker.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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 Key5719014
MDR Text Key47189104
Report Number3004753838-2016-03417
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 05/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTR-DR-001
Device Lot Number5211731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3004753838-02/29/16-001C

Patient Treatment Data
Date Received: 06/10/2016 Patient Sequence Number: 1
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