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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 Problem Imprecision (1307)
Patient Problem Headache (1880)
Event Date 12/20/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and high glucose values. The sensor was inserted into the abdomen on (b)(6) 2017. The patient stated that the cgm was showing 55 mg/dl so she started taking in food to increase her bg levels. The patient's blood sugar level increased to 722 mg/dl and started to have a headache and took 10 units of insulin to lower her bg levels. The patient did not feel the need to call the doctor. At the time of contact, the patient was feeling better. Additional patient or event information is not available. Data was received for evaluation, data review confirmed the reported event of inaccurate cgm values. A root cause could not be determined via data.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4), that on (b)(6), the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and high glucose values.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6)2017, that on (b)(6)2017, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and high glucose values.
 
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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 Key7198002
MDR Text Key97468779
Report Number3004753838-2018-05864
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/27/2018
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
Device Lot Number5228473
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 Received01/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2017
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: 01/16/2018 Patient Sequence Number: 1
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