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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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-2
Device Problem Defective Alarm (1014)
Patient Problems Headache (1880); No Consequences Or Impact To Patient (2199); Injury (2348); Shaking/Tremors (2515)
Event Date 02/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 02/07/2017 that on (b)(6) 2017 the receiver had intermittent audio output. No additional event or patient information is available. No product or data were provided for evaluation. The reported intermittent audio output could not be confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient experienced a low blood glucose event with minor injury on (b)(6) 2017. The patient stated that he had woken up after having very low glucose levels below 2. 5mmol/l for several hours because the alarm did not go off. The patient stated that he had felt very unwell, very sore head, shaky, lethargic. This lasted for several hours and the patient didn't feel well until the next day. No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint receiver device was returned for evaluation. The device was visually inspected and no defects were found. The receiver was charged and rebooted. A manual test was performed and speaker sounded. The reported event of an intermittent audio output was not confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and failed due to missing usb door. The receiver will charge and boot. Performed receiver download and unit passed try it fixed low test and passed. Open receiver and measure speaker resistance. Finding related to complaint in receiver download show no issues related to customer complaint. The reported event of an intermittent audio output was not confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING 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 Key6380924
MDR Text Key69168767
Report Number3004753838-2017-14854
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-109
Device Lot Number5191172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2014
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: 03/06/2017 Patient Sequence Number: 1
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