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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems Hyperglycemia (1905); Urinary Tract Infection (2120)
Event Date 12/27/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2015, to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2015, resulting medical intervention due to a hyperglycemic event. Patient upset stated because of her inaccurate readings she missed an extremely high bg, ended up in the emergency room (er). The patient stated on monday (b)(6) 2015 she wasn't feeling well. Patient went to a walk in clinic where the clinic staff administrated tests. Clinic learned the patient had a bg reading of 600mg/dl, patient also had a urinary tract infection (uti) and a possible kidney infection. The patient is still waiting for other test results, types of tests were not specified. The patient was prescribed ciprofloxacin and diflucan for her issues. At the time of contact, patient stated her condition is stable and she's doing okay. No additional intervention or patient information was reported. The complaint device was not returned for evaluation. The receiver data log was provided by the patient. The data was reviewed, and the reported event of inaccurate blood glucose values on (b)(6) 2015 cannot be confirmed. A root cause for the reported inaccuracies cannot be determined. Additionally, it should be noted that diabetes mellitus is a known cause of hyperglycemia, uti and possible kidney infection.
 
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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 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 Key5389475
MDR Text Key36804365
Report Number3004753838-2016-35303
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 12/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2016
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 Received12/28/2015
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

Patient Treatment Data
Date Received: 01/25/2016 Patient Sequence Number: 1
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