Events

Device Recall Dexcom G4 PLATINUM Receiver 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dexcom Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    73412
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1334-2016
  • 사례 시작날짜
    2016-02-23
  • 사례 출판 날짜
    2016-04-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144153
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Sensor, glucose, invasive - Product Code MDS
  • 원인
    Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
  • 조치
    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

Device

Device Recall Dexcom G4 PLATINUM Receiver
  • 모델명 / 제조번호(시리얼번호)
    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 5067193 5067194 5067195 5069027 5069028 5069029 5069030 5069031 5069032 5069033 5069034 5073057 5073058 5073059 5073060 5073061 5073062 5073063 5073064 5073065 5073066 5073067 5073068 5073069 5073070 5073071 5073072 5073073 5076223 5076224 5076225 5076226 5076227 5076229 5076305 5076306 5076307 5076308 5076309 5076310 5076311 5076312 5076313 5076314 5078033 5078034 5079118 5079119 5079120 5079121 5079122 5079123 5079124 5086279 5086280 5086281 5086282 5089155 5090161 5091222 5091223 5091224 5091225 5091227 5091228 5091229 5091230 5091232 5091233 5091234 5091237 5091238 5091239 5100224 5101229 5101230 5105229 5105259 5106224 5106228 5106229 5106230 5106240 5106241 5106242 5106247 5106248 5117263 5117264 5117265 5117266 5117267 5117268 5117269 5117284 5117285 5117286 5117287 5117289 5118235 5118236 5118237 5118238 5118239 5129232 5130241 5130273 5131279 5131284 5131285 5131352 5131386 5131387 5131393 5131394 5132233 5132234 5134295 5134296 5134297 5134428 5134429 5134463 5134464 5134489 5134490 5134491 5134492 5134493 5134494 5135388 5135390 5135391 5135393 5136488 5136489 5142421 5145460 5148413 5148414 5150442 5150443 5150444 5150445 5155414 5155415 5159484 5166417 5166418 5166419 5166420 5166421 5166422 5167424 5178452 5178453 5179425 5179426 5179427 5179428 5179429 5187478 5188582 5188749 5188750 5190868 5191108 5191116 5191117 5191118 5191119 5191120 5191121 5191122 5191730 5191731 5191732 5191733 5191994 5192964 5193918 5193919 5193920 5194315 5194316 5195029 5195030 5195031 5195042 5195118 5195128 5195253 5195254 5195289 5195351 5195355 5195442 5195443 5195447 5195448 5195751 5195771 5195772 5195773 5195774 5195775 5195777 5195960 5195961 5195964 5195970 5195971 5195977 5196010 5196013 5196088 5196135 5196136 5196137 5196140 5196141 5196142 5196143 5197030 5197031 5197600 5197601 5197602 5197603 5197604 5208965 5210024 120618442 120718429 120727412 120727413 120731438 120919402 120921480 120927480 120928458 121126447 130821432 130923435 131003418 131118445 5045840 5045841 5045842 5045843 5045844 5045845 5045846 5046316 5046317 5046377 5046378 5046379 5046380 5046381 5046382 5046383 5046384 5046385 5046386 5046387 5046388 5046389 5046390 5046391 5046392 5046393 5046394 5046395 5046396 5046397 5047796 5047797 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  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Dexcom Inc

Manufacturer

Dexcom Inc
  • 제조사 주소
    Dexcom Inc, 6340 Sequence Dr, San Diego CA 92121-4356
  • 제조사 모회사 (2017)
    Dexcom Inc.
  • Source
    USFDA