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U.S. Department of Health and Human Services

Class 1 Device Recall Dexcom G4 PLATINUM Receiver

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  Class 1 Device Recall Dexcom G4 PLATINUM 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-1337-2016
Recall Event ID 73412
PMA Number P120005S028 
Product Classification Sensor, glucose, invasive - Product Code MDS
Product Dexcom G4 PLATINUM Receiver with Share
Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK,
Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue.
Intended to detect trends and track glucose patterns in persons with diabetes.
Code Information Receiver Kit Number: STK-DR-001 STK-RR-001 STR-DR-001 STK-DR-PNK STK-RR-PNK STR-DR-PNK STK-DR-BLU STK-RR-BLU STR-DR-BLU  Lot Number: 5197900 5197901 5197902 5197903 5197904 5197905 5197906 5197907 5197908 5197909 5197962 5197964 5197965 5198423 5198424 5198425 5198432 5198433 5198446 5198448 5198455 5198456 5198457 5198463 5198493 5198495 5198496 5198497 5198505 5198506 5198557 5198558 5198559 5198560 5198561 5198567 5198607 5198608 5198894 5198895 5199491 5200521 5200548 5200612 5200682 5200688 5200833 5200834 5201244 5201245 5201282 5201292 5201378 5201380 5201418 5201419 5201420 5201422 5201423 5202036 5202037 5202038 5202039 5202040 5202041 5202042 5202043 5202044 5202045 5202046 5202047 5202048 5202049 5202050 5202051 5202052 5202247 5202301 5202304 5202410 5202411 5202426 5202776 5202777 5202786 5202787 5202796 5202797 5202866 5202869 5202873 5202879 5203264 5203296 5203305 5203315 5203323 5203324 5203503 5204322 5204943 5204949 5205009 5205058 5206616 5206626 5206726 5207988 5208004 5208038 5208514 5208516 5208520 5208809 5208888 5209615 5209667 5209671 5210272 5197928 5197929 5197930 5197931 5197932 5197969 5197983 5198394 5198395 5198414 5198415 5198417 5198426 5198428 5198429 5198449 5198893 5199015 5199034 5199035 5199211 5199212 5200520 5200549 5200611 5200686 5200828 5201241 5201242 5201246 5201259 5201260 5201261 5201406 5201407 5201409 5201410 5201411 5202026 5202028 5202029 5202030 5202031 5202032 5202033 5202034 5202111 5202116 5202129 5202305 5202422 5202732 5202781 5202792 5202865 5202870 5202872 5203284 5203321 5203325 5203473 5204315 5204318 5204948 5205016 5206631 5208010 5208379 5208521 5208889 5209672 5209673 5210392 5197944 5197972 5197974 5197978 5197979 5197980 5198483 5198508 5198509 5198510 5198903 5199014 5199161 5199463 5199464 5199466  5200552  5200553 5200613 5200681 5201240 5201357 5201358 5201359 5201400 5201401 5201402 5201403 5201999 5202000 5202001 5202002 5202018 5202019 5202020 5202021 5202022 5202108 5202109 5202160 5202303 5202416 5202800 5202874 5202894 5202895 5203281 5203282 5203283 5203329 5203475 5203483 5204312  5204316  5204319 5204320 5204954 5205013 5206628 5207991 5208043 5208934 5209674 5209675 5197918 5197919 5197920 5197921 5197922 5198462 5198498 5198564 5201262 5201281 5201374 5201375 5201466 5202056 5202057 5202058 5202059 5202122 5202123 5202309 5202430 5202783 5202817 5202867 5202868 5203263 5203312 5203463 5203531 5204314 5204326 5204329 5204958 5205012 5209682 5209683 5197926 5197927 5197940 5197985 5200840 5201377 5202035 5202124 5202125 5202306 5202728 5202904 5203288 5204323 5204961 5209686 5209687 5197941 5197942 5197943 5198507 5201355 5201356 5202023 5202024 5202110 5202413 5202730 5202788 5202818 5202903 5203285 5203464 5204324 5205032 5209684 5197924 5198563 5200829 5200830 5200831 5200832 5200908 5200909 5201424 5202112 5202113 5202114 5202300 5202310 5202427 5202784 5203294 5203319 5204960 5206581 5207990 5208800 5209495 5210017 5210034 5210386 5197933 5198892 5200836 5200837 5200838 5200910 5200911 5201258 5202419 5202782 5202798 5203469 5205005 5206582 5207981 5208277 5208404 5208522 5209389 5209499 5210018 5210035 5210389 5197984 5198555 5200913 5200914 5200920 5200921 5201405 5202414 5202880 5204327 5204997 5206566 5207975 5208342 5208377 5208517 5209502 5210019 5210023 5210037
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 53,106
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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