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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 Problems Hypoglycemia (1912); Vomiting (2144); Weakness (2145)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and an adverse event. The sensor was inserted into the abdomen on (b)(6) 2018. The patient's partner stated the patient had experienced a hypoglycemic event. They stated that the patient started vomiting, had dry mouth and was slightly feeling weak, so they brought the patient to the doctor and then was transferred to the hospital where the patient was treated with a drip-feed (contents unknown) during the ambulance ride to the hospital. When the patient arrived at the hospital, their bg was taken by the hospital and the meter read 12. 5mmol/l. They indicated that the patient was sent to the intensive care unit (icu) and the sensor was removed from the patient's body on (b)(6) 2018. Treatment at the hospital is unknown. Further contact was made with the patient on (b)(6) 2018 and it was reported that the patient was released from the hospital on (b)(6) 2018. They had been hospitalized because their glucose values were fluctuant with highs during the day. Additionally, at the time of event, the patient did not know what the cgm was reading; however, they assumed the values were inaccurate. It was further reported that the patient had stopped using the dexcom system and their insulin pump until they can discuss other options for glucose monitoring with their diabetes advisor. The patient had stated they are measuring their glucose with a bg meter. No additional patient or event information is available. 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 Key7699152
MDR Text Key114339379
Report Number3004753838-2018-79044
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
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: 07/18/2018 Patient Sequence Number: 1
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