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U.S. Department of Health and Human Services

Class 1 Device Recall Dexcom G5 Mobile Receiver

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  Class 1 Device Recall Dexcom G5 Mobile 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-1339-2016
Recall Event ID 73412
PMA Number P120005S033 
Product Classification Sensor, glucose, invasive - Product Code MDS
Product Dexcom G5 Mobile Receiver
Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK,
Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue.
Intended to detect trends and track glucose patterns in persons with diabetes.
Code Information Receiver Kit Number: STK-GF-001 STK-RF-001 STR-GF-001 STK-GF-PNK STK-RF-PNK STR-GF-PNK STK-GF-BLU STK-RF-BLU STR-GF-BLU  Lot Number: 5204518 5204520 5204526 5204529 5204546 5204644 5204647 5204697 5204752 5204756 5204760 5204764 5204941 5204959 5204995 5205003 5205015 5205024 5205039 5205057 5205059 5206564 5206577 5206601 5206618 5206630 5206724 5207977 5207978 5207983 5207994 5208000 5208001 5208013 5208014 5208017 5208026 5208027 5208030 5208034 5208263 5208264 5208349 5208350 5208512 5208515 5208524 5208525 5208799 5208803 5208817 5209310 5209311 5209313 5209657 5209660 5210388 5210468 5204519 5204525 5204528 5204545 5204645 5204648 5204698 5204754 5204758 5204952 5205007 5205029 5205050 5206565 5206576 5206606 5206623 5207980 5207987 5207996 5208009 5208513 5208523 5208815 5209314 5209317 5209319 5209658 5209661 5210391 5204521 5204527 5204530 5204646 5204699 5204757 5204761 5204947 5205008 5205036 5205045 5206569 5206615 5206622 5206653 5206657 5206725 5208024 5208519 5208808 5208822 5209320 5209659 5209662 5210397 5210475 5204522 5204539 5204687 5204753 5204953 5204999 5205011 5205035 5206570 5206580 5206610 5209664 5209694 5204523 5204540 5204690 5204783 5204996 5205019 5205061 5206568 5209665 5209669 5204524 5204541 5204693 5204759 5205004 5205062 5206578 5209666 5209670 5204542 5204694 5204955 5205023 5205044 5205052 5209919 5210031 5210040 5210395 5210474 5204543 5204695 5204956 5205030 5205056 5209920 5210032 5210396 5204544 5204696 5204957 5205017 5205040 5210016 5210033
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 41,925
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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