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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 9500-44
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Pregnancy (3193)
Event Date 05/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia. Additional events referenced are being reported under the following mfrs: 3004753838-2018-67279, 3004753838-2018-67280, 3004753838-2018-67281.
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2016, the patient experienced an adverse event. Date of issue is an approximation. It was reported that the patient experienced hypoglycemic episodes and on 4 occasions, the paramedics were called to her house. It is unclear of what the issue with the dexcom continuous glucose monitor (cgm) was at the time of event. No additional patient or event information is available. Reportedly, the patient used cgm while pregnant against user guide recommendations. Labeling indicates: the dexcom system is not approved for use in children or adolescents, pregnant women or persons on dialysis. No data or product was provided for evaluation. The complaint confirmation was unable to be determined. A root cause was not 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 Key7622735
MDR Text Key111828006
Report Number3004753838-2018-67282
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 foreign,other
Reporter Occupation
Type of Report Initial
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/20/2018 Patient Sequence Number: 1
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