• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-35
Device Problem Imprecision (1307)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 07/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred. The sensor was inserted into the abdomen on (b)(6) 2019. No data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. The reported glucose values fall within the c zone of the parkes error grid. The patient¿s wife reported that the patient¿s cgm alerted for low glucose. The patient was found in the bathroom seizing. The cgm receiver displayed 4. 0 mmol/l with double arrows pointing down. The receiver readings were updated and the cgm displayed 2. 8 mmol/l. A blood glucose was not obtained prior to the arrival of emergency medical services because of the patient¿s seizure. Emergency medical services were called; the patient¿s blood glucose meter reading per emergency medical services was 1. 7 mmol/l. The patient was treated with glucagon 1 mg and transported to the hospital with a blood glucose meter measurement of 11 mmol/l. The patient was conscious at the time of transport. The patient was discharged from the hospital the following day without any report of long-term effect. At the hospital, the patient¿s wife indicated that the patient¿s cgm values were stable at 5. 8 mmol/l and increased to 8. 8 mmol/l earlier in the evening prior to the event. The event occurred the day after the sensor had been inserted into the abdomen. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ying chen
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8918289
MDR Text Key155179493
Report Number3004753838-2019-061424
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-35
Device Catalogue NumberSTS-GL-007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2019
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: 08/21/2019 Patient Sequence Number: 1
-
-