Class 1 Device Recall Dexcom G4 PLATINUM Receiver

• Date Initiated by Firm: February 23, 2016
• Date Posted: April 11, 2016
• Recall Status: Terminated on August 11, 2017
• Recall Number: Z-1334-2016
• Recall Event ID: 73412
• PMA Number: P120005S002
• Product Classification: Sensor, glucose, invasive - Product Code MDS
• Product: Dexcom G4 PLATINUM Receiver; Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue.; Intended to detect trends and track glucose patterns in persons with diabetes.
• Code Information: Receiver Kit Number: STK-GL-001 STK-RX-001 STR-GL-001 STK-GL-PNK STK-RX-PNK STR-GL-PNK STK-GL-BLU STK-RX-BLU STR-GL-BLU Lot Number: 2009655 5022776 5022797 5032813 5032814 5032815 5039607 5045819 5045820 5045821 5045822 5045823 5045824 5045825 5045826 5045827 5046248 5046249 5046250 5046251 5046252 5046254 5046344 5046345 5046346 5046347 5046348 5046349 5046350 5046351 5046352 5046353 5046354 5046355 5046356 5046464 5046465 5046466 5046467 5046468 5046469 5047822 5047823 5047824 5047825 5047826 5047827 5047828 5047829 5047830 5049500 5049501 5049502 5049503 5049504 5049505 5049506 5049507 5049508 5049509 5049510 5049511 5049512 5049513 5049514 5049515 5053609 5053610 5053611 5053612 5053613 5053614 5053615 5053616 5053617 5053618 5053619 5053620 5053621 5053622 5053623 5053624 5055634 5055635 5055636 5055637 5060693 5067169 5067170 5067171 5067172 5067173 5067174 5067175 5067176 5067181 5067182 5067183 5067184 5067185 5067187 5067188 5067189 5067190 5067191 5067192 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• 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: 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: 131,768
• 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.