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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
Device Problem Failure to Charge (1085)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the receiver would not charge. No additional patient or event information is available. The receiver has been received for evaluation. An external visual inspection was performed and the receiver passed. A receiver charge and boot was performed and the receiver passed. The receiver log was downloaded and a hwrf was found in the logs during the incident date. Receiver functional tests were performed and the receiver passed all relevant tests. The receiver case was opened and the receiver passed the internal visual inspection. Additionally, numerous rf command retry and atmel rebooting rf was found in the logs along with a screen error alarm. The customer complaint of the receiver not charging was confirmed. The root cause was determined to be a hardware error. The reported issue of the receiver not charging is reportable based on the finding of a hardware error.
 
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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 dr.
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key6876733
MDR Text Key87306625
Report Number3004753838-2017-66246
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000153
UDI-Public10386270000153
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
Report Date 07/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTK-DR-001
Device Lot Number5220702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2016
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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