• 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 9500-44
Device Problems Imprecision (1307); Use of Device Problem (1670)
Patient Problem Loss of consciousness (2418)
Event Date 09/30/2017
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 an adverse event.The sensor was inserted into the abdomen on (b)(6) 2017.On the morning of (b)(6) 2017 at approximately 12:15 am, the patient's mother checked on the patient and was unable to wake them up because they were unconscious.The patient's mother and father proceeded to administer the patient with 2 glucagon shots and after 20 minutes, the patient was alert and awake.At 12:45 am, the patient was given fruit to eat.At the time of contact, the patient was doing good.No additional patient or event information is available.No data was provided for evaluation.The reported event of inaccuracies was unable to be determined.A root cause could not be determined.It was reported that the patient used multiple bg meters throughout the same sensor session.Dexcom labeling indicates: use the same meter you routinely use to measure your blood glucose to calibrate.Do not switch your meter in the middle of a sensor session.Blood glucose meter and strip accuracy vary between blood glucose meter brands.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key6983608
MDR Text Key90431935
Report Number3004753838-2017-91793
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 Other
Type of Report Initial
Report Date 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9500-44
Device Catalogue NumberSTS-GF-007
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/04/2017
Initial Date FDA Received10/27/2017
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
Patient Weight40
-
-