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U.S. Department of Health and Human Services

Class 1 Device Recall Dexcom G4 PLATINUM (Professional) Receiver

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  Class 1 Device Recall Dexcom G4 PLATINUM (Professional) Receiver see related information
Date Initiated by Firm February 23, 2016
Date Posted April 11, 2016
Recall Status1 Terminated 3 on August 11, 2017
Recall Number Z-1336-2016
Recall Event ID 73412
PMA Number P120005S018 
Product Classification Sensor, glucose, invasive - Product Code MDS
Product Dexcom G4 PLATINUM (Professional) Receiver
Receiver Part Number: MT20649 Receiver (mg/dL), Black.
Intended to detect trends and track glucose patterns in persons with diabetes.
The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
Code Information Receiver Kit Number: STK-PU-001  Lot Number: 5176532 5176533 5176534 5176535 5176536 5188586 5189596 5190560 5191152 5191737 5191738 5192934 5193038 5194193 5194322 5195147 5195148 5195352 5195803 5195913 5196152 5197013 5197677 5198614 5200903 5200904 5200916 5201455 5201669 5202100 5202149 5202429 5202646 5202790 5202795 5202803 5202804 5202906 5203313 5203474 5203485 5203536 5204330 5204333 5205041 5206612 5206643 5208018 5208332 5208810 5210472 
Recalling Firm/
Manufacturer		 Dexcom Inc
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information Contact Dedicated Hotline
844-607-8398
Manufacturer Reason
for Recall		 Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
FDA Determined
Cause 2		 Device Design
Action Dexcom sent out a customer notification letter by certified mail to all direct customers on 02/23/16 notifying customers that they may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. As a result customers may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event. The letter instructs the customer to peridically test the alarms and alerts on their receiver to make sure that the alarms and alerts are functioning properly (especially if the receiver gets wet of is dropped). Receiver part numbers and instructions for testing the alarms and alerts can be found on the back of the notification as well as in the User's Guide. Should customers find that alarms and alerts are not functioning properly or if any questions regarding the notification contact the deciated hotline tool free at 844-607-8398 or dial 858-291-1700. The healthcare professional notification that was sent out provided similar instructions as the direct customer notificaiton in which it is recommended that healthcare professionals periodically check the speaker function by following the testing instructions attached in the notification. The distributor notification letter instructed them to take the following actions: Hold shipments of Dexcom receivers and sticker all existing Dexcom receiver boxes on the outside front of the box with the enclosed notification stickers (see the attached visual guide for sticker placement). Once completed can begin shipping the products. In order to ensure that the notification is timely received by patients select one of the following two (2) options by no later than February 25, 2016: Send, via certified mail, the notification directly to those patients that have purchased a Dexcom receiver from you. If elect this option, Dexcom will provide the required quantity of notifications enclosed in certified mail envelopes. In order to facilitate this effort email the number of notifi
Quantity in Commerce 5,722
Distribution Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MDS and Original Applicant = DEXCOM, INC.
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