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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 SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 9500-35
Device Problem Imprecision (1307)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2020
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading. Reportedly, the cgm bg reading was 198 mg/dl, and the meter bg reading was 361 mg/dl. No additional patient or event information was available. A root cause could not be determined. A replacement sensor was sent to the customer.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
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
mick trier
san diego, CA 92121
8584011451
MDR Report Key9963625
MDR Text Key187868947
Report Number3013756811-2020-38732
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
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 04/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-35
Device Catalogue NumberSTS-GF-007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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