Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM G4 PLATINUM (PEDIATRIC)
  • 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 G4 PLATINUM (PEDIATRIC) Back to Search Results
Model Number G4 PLATINUM (PEDIATRIC)
Device Problems Use of Device Problem (1670); Application Program Problem (2880); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Information (3190)
Event Type  Other  
Event Description
My daughter started using the dexcom g4 continuous glucose monitoring system in 2014.When we received the product our training was all conducted on the phone by dexcom employees and via the user manual and online resources dexom provided.Dexom promotes "peace of mind" and users are encouraged to rely on alarms for high blood sugar, low blood sugar, failed sensors and when the receiver and transmitter are "out of range" of each other.Unfortunately what they do not tell you is that there are two failed modes that can go on indefinitely with no built in alarm.They are referred to in the user guide in section 9.4 as a system glucose error.When a user receives a system glucose error.When a user receives a system glucose error they get a "???" or an hourglass symbol "these symbols mean the receiver does not understand the sensor signal temporarily." if a user wants to set an alarm for any of the other instances where data is no longer being transmitted, they can do so.My issue is that not only is this fatal flaw completely ignored in the user manual, training and support of the device, there are no plans to fix it on the base unit.Even if a user has purchased the upgrade and is using the model with "share" capability, they are at risk.If they have an interruption in mobile or internet service or their phone is dead, the base unit cannot be trusted to alarm when in these two modes.As a user of this device, it is imperative that the dangers associated with this flaw are resolved.User must be notified as soon as possible for safety reasons.In my personal experience, this system glucose error does occur, specifically at night when a use is often most at risk.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
G4 PLATINUM (PEDIATRIC)
Type of Device
G4 PLATINUM (PEDIATRIC)
Manufacturer (Section D)
DEXCOM
MDR Report Key4869367
MDR Text Key6261396
Report NumberMW5043226
Device Sequence Number1
Product Code MDS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberG4 PLATINUM (PEDIATRIC)
Device Catalogue NumberMT22430-PNK
Other Device ID Number67574
Patient Sequence Number1
Treatment
RX MEDS: HUMALOG; MELATONIN; ANIMAS ONE TOUCH PING PUMP; OTC MEDS: MULTIVITAMIN; BLOOD SUGAR MONITOR DEXCOM G4 CONTINUOUS GLUCOSE
Patient Age6 YR
Patient Weight20
-
-