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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 9500-27
Device Problems Use of Device Problem (1670); Invalid Sensing (2293)
Patient Problem Seizures (2063)
Event Date 06/08/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2016. The sensor was inserted on 06/08/2016. Patient stated that her cgm was reading 321mg/dl and gave herself humalog insulin to counteract the high readings. Patient had a seizure which lead to the patient's husband giving the patient glucose tablets. The patient did not take a fingerstick reading before treating and based dosage off the cgm readings. Patient state that the event was due to the cgm's inaccuracies. At the time of contact, the patient was healthy and at home. No additional event or patient information was provided. The patient made treatment decisions based on cgm values. The dexcom g5 mobile continuous glucose monitoring system states: the dexcom g5 mobile cgm system does not replace your bg meter. When making treatment decisions, such as the amount of insulin you need, only use your bg value. Don't use the dexcom g5 mobile cgm system sensor glucose readings because readings can be different from your bg value. If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.
 
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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 Key5788561
MDR Text Key49361108
Report Number3004753838-2016-38674
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
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/12/2016 Patient Sequence Number: 1
Treatment
ZQUIL
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