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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 Imprecision (1307); Use of Device Problem (1670)
Patient Problems Hypoglycemia (1912); Pregnancy (3193)
Event Date 04/21/2016
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, 3004753838-2018-67282.
 
Event Description
Dexcom was made aware on 05/22/2018, that on (b)(6) 2016, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and an adverse event. It was reported that the patient was pregnant and admitted to the hospital on (b)(6) 2016. During her stay at the hospital, it was indicated that she had a significant number of hypoglycemic episodes, which continued after she was discharged and on 4 occasions, the paramedics were called to her house. It was determined by the hospital that the cgm was giving faulty reading that were too high. No further event or patient 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 Key7622718
MDR Text Key111830109
Report Number3004753838-2018-67278
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? Yes
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? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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