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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 MT22719-BLU
Device Problem Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report the receiver initialized without a manual restart on (b)(6) 2016. There was no report injury or medical intervention. No additional patient or event information is available. Data download log was provided by the patient and reviewed for evaluation on (b)(6) /2016. Complaint for initializing screen without manual restart error could not be confirmed. The root cause could not be determined post investigation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and there was no failure detected related to the complaint. The receiver log was reviewed and screen error alarms and firmware errors were observed. The reported event of initializing screen without manual restart was confirmed during log review. 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 Key5449443
MDR Text Key39020681
Report Number3004753838-2016-36092
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 01/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-BLU
Device Catalogue NumberSTK-GF-BLU
Device Lot Number5204754
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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