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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 Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2016
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 of any injury or medical intervention. No additional patient or event information is available.
 
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 firmware errors and screen error alarms 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 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 Key5433472
MDR Text Key38436372
Report Number3004753838-2016-05727
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 01/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTR-DR-001
Device Lot Number5208800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2015
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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