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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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM Back to Search Results
Model Number MT22495-BLU
Device Problems Use of Device Problem (1670); Device Issue (2379); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the receiver displayed a firmware error. There was no report of injury or medical intervention. No additional patient or event information is available. It was reported that a pediatric patient was using a receiver approved only for adults. It should be noted that the dexcom g4® platinum continuous glucose monitoring system states: the dexcom g4 system is not approved for use in children or adolescents, pregnant women or persons on dialysis. However, a root cause for the reported firmware error cannot be determined. It was reported that a pediatric patient was using a receiver approved only for adults. It should be noted that the dexcom g4® platinum continuous glucose monitoring system states: the dexcom g4 system is not approved for use in children or adolescents, pregnant women or persons on dialysis. The device has been received for evaluation. A follow-up report will be submitted once the evaluation is complete.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defect was found. The receiver log was reviewed and screen error alarms and firmware errors were observed. The reported event of a firmware error was confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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 Key5931150
MDR Text Key54028114
Report Number3004753838-2016-83328
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 08/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495-BLU
Device Catalogue NumberSTR-DR-BLU
Device Lot Number5214764
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2016
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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