Class 1 Device Recall Dexcom G4 PLATINUM (Pediatric) Receiver

• Date Initiated by Firm: February 23, 2016
• Date Posted: April 11, 2016
• Recall Status: Terminated on August 11, 2017
• Recall Number: Z-1335-2016
• Recall Event ID: 73412
• PMA Number: P120005S011
• Product Classification: Sensor, glucose, invasive - Product Code MDS
• Product: Dexcom G4 PLATINUM (Pediatric) Receiver; Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics).; Intended to detect trends and track glucose patterns in persons with diabetes.
• Code Information: Receiver Kit Number: STK-KD-001 STK-KX-001 STR-KD-001 STK-KD-PNK STK-KX-PNK STR-KD-PNK STK-KD-BLU STK-KX-BLU STR-KD-BLU Lot Number: 5120310 5135364 5135371 5136498 5150416 5150452 5159486 5166429 5166430 5178449 5179449 5187476 5189594 5190724 5191132 5191133 5191174 5191809 5191810 5191849 5192890 5194119 5194120 5194121 5194431 5195411 5195746 5195763 5195776 5195784 5196133 5196159 5197032 5197033 5197647 5120312 5135362 5135368 5135380 5136502 5139380 5150418 5150454 5153433 5159487 5166433 5166449 5166450 5171430 5178418 5178456 5179453 5187474 5189590 5190725 5191105 5191134 5191135 5191408 5191839 5191840 5191841 5192942 5193958 5193959 5193960 5194123 5194432 5194433 5195412 5195459 5195747 5195766 5195965 5195969 5195972 5196087 5196134 5196918 5197034 5197035 5197614 5197615 5120311 5135363 5135366 5135381 5136500 5139379 5150417 5150453 5159488 5166434 5166435 5171431 5178451 5179451 5187426 5187475 5188748 5191106 5191136 5191409 5191836 5191837 5193810 5194186 5194335 5194400 5194563 5195413 5195745 5195768 5195785 5195973 5197036 5197037 5197038 5197608 5126237 5135369 5136504 5142406 5142408 5142415 5167425 5179455 5189600 5194188 5194562 5195759 5195786 5196151 5197648 5126238 5135370 5136505 5142417 5167426 5176427 5179457 5189602 5191151 5191838 5194192 5195760 5195787 5197563 5197649 5126239 5135361 5139386 5142416 5167427 5179456 5189601 5191103 5194190 5194191 5195761 5196995 5197650 5120293 5135365 5150455 5153439 5166437 5179450 5191101 5191811 5194201 5195416 5195966 5197505 5197571 5197676 5201468 5120294 5135379 5139382 5150439 5152419 5166440 5173415 5178458 5179454 5187477 5191099 5191410 5191812 5191848 5194202 5194561 5195415 5195750 5195793 5195967 5195976 5196156 5196157 5197641 5197642 5198439 5120309 5135367 5139381 5153441 5166438 5179452 5189593 5191100 5191813 5194212 5194213 5194565 5195414 5195764 5195968 5197638 5197639 5197678 5198441 5201469
• 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: 18,004
• 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.