Description of Event or Problem · 0
DEAR (B)(6), THANK YOU FOR CONTACTING THE DIVISION OF INDUSTRY AND CONSUMER EDUCATION (DICE) AT FDA'S (FOOD AND DRUG ADMINISTRATION'S) CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), (B)(4) E-MAIL ACCOUNT. I AM SORRY FOR YOUR FRUSTRATION, AS YOU STATED: "MY SON, (B)(6), IS IN THE ICU (INTENSIVE CARE UNIT) DUE TO THE DEXCOM 6 CONTINUOUSLY FAILING. THIS DEVICE IS USED WITH THE TANDEM INSULIN PUMP AND COMMUNICATES HIS BLOOD SUGAR SO THE INSULIN PUMP CAN REGULATE HIS BLOOD SUGAR. WHEN IT WORKS, IT CAN BE AMAZING; HOWEVER, IT CONSTANTLY FAILS....HE WAS ADMITTED TO THE ER (EMERGENCY ROOM) ON YESTERDAY AND I CALLED AND THEY CLAIMED IT WOULD ARRIVE ON YESTERDAY BEFORE 8PM. IT DID NOT ARRIVE. I CALLED THIS MORNING AND SPOKE WITH (B)(4) WHO SAID HE WOULD ESCALATE THE INCIDENT." CONSIDER FILING AN FDA COMPLAINT, USING THE ATTACHED DOCUMENT TITLED FORM 3500B, AS WELL AS, CONTACT OUR ALLEGATIONS AND MISCONDUCT TEAM. THE ATTACHED DOCUMENT HAS BOTH OF THESE AS REFERENCED. YOU CAN ALSO FILE A COMPLAINT BY CONTACTING DEXCOM'S 6 OFFICIAL CORRESPONDENT (SEE BOTTOM OF PAGE). ESTABLISHMENT: DEXCOM, INC. (B)(4), REGISTRATION NUMBER: (B)(4). FEI NUMBER*: (B)(4). STATUS: ACTIVE. DATE OF REGISTRATION STATUS: 2023 OWNER/OPERATOR: DEXCOM, INC. (B)(4). OWNER/OPERATOR NUMBER: (B)(4). OFFICIAL CORRESPONDENT: (B)(4). (B)(4). PHONE: (B)(4). I HOPE YOU FIND THIS HELPFUL. SINCERELY, CONSUMER TEAM DIVISION OF INDUSTRY AND CONSUMER EDUCATION OFFICE OF COMMUNICATION AND EDUCATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, U.S. FOOD AND DRUG ADMINISTRATION. EXCELLENT CUSTOMER SERVICE IS IMPORTANT TO US. PLEASE TAKE A MOMENT TO PROVIDE FEEDBACK REGARDING THE CUSTOMER SERVICE YOU HAVE RECEIVED: HTTPS://WWW.RESEARCH.NET/R/CDRHCUSTOMERSERVICE?O=800&D=870&B=872&E=&S=E. THIS COMMUNICATION IS CONSISTENT WITH 21 CFR 10.85 (K) AND CONSTITUTES AN INFORMAL COMMUNICATION THAT REPRESENTS MY BEST JUDGMENT AT THIS TIME BUT DOES NOT CONSTITUTE AN ADVISORY OPINION, DOES NOT NECESSARILY REPRESENT THE FORMAL POSITION OF FDA, AND DOES NOT BIND OR OTHERWISE OBLIGATE OR COMMIT THE AGENCY TO THE VIEWS EXPRESSED. THIS COMMUNICATION IS INTENDED FOR THE EXCLUSIVE USE OF THE RECIPIENT(S) NAMED IN THIS CORRESPONDENCE. IT MAY CONTAIN INFORMATION THAT IS PROTECTED, PRIVILEGED, OR CONFIDENTIAL, AND IT SHOULD NOT BE MODIFIED. IT MAY NOT BE DISSEMINATED, DISTRIBUTED, REPRODUCED, OR COPIED TO PERSONS NOT AUTHORIZED TO RECEIVE SUCH INFORMATION. IF YOU ARE NOT THE INTENDED RECIPIENT, ANY DISSEMINATION, DISTRIBUTION, OR COPYING IS STRICTLY PROHIBITED. IF YOU THINK YOU HAVE RECEIVED THIS COMMUNICATION IN ERROR, PLEASE IMMEDIATELY DELETE ALL COPIES FROM THE SAVED SOURCES AND NOTIFY DICE BY EMAIL AT: (B)(6) IMMEDIATELY. ORIGINAL MESSAGE FROM: (B)(6). SENT: 8/15/2023. SUBJECT: DEXCOM 6 GLUCOMETER. MESSAGE: MY SON, (B)(6), IS IN THE ICU DUE TO THE DEXCOM 6 CONTINUOUSLY FAILING. THIS DEVICE IS USED WITH THE TANDEM INSULIN PUMP AND COMMUNICATES HIS BLOOD SUGAR SO THE INSULIN PUMP CAN REGULATE HIS BLOOD SUGAR. WHEN IT WORKS, IT CAN BE AMAZING; HOWEVER, IT CONSTANTLY FAILS. HE CALLED DEXCOM ON (B)(6) 2023 FOR A REPLACEMENT SENSOR. HE RECEIVES THREE SENSORS PER MONTH, AND THE FIRST SENSOR WORKED, BUT THE LAST TWO FAILED. HE CALLED AGAIN LAST THURSDAY, (B)(6), 2023, AND THEY SAID THEY WOULD SHIP SUPPLIES EXPEDITIOUSLY. HE WAS ADMITTED TO THE ER ON YESTERDAY AND I CALLED AND THEY CLAIMED IT WOULD ARRIVE ON YESTERDAY BEFORE 8PM. IT DID NOT ARRIVE. I CALLED THIS MORNING AND SPOKE WITH (B)(6) WHO SAID HE WOULD ESCALATE THE INCIDENT. HE IS NOT SURE WHEN MY SON WILL RECEIVE HIS MEDICAL EQUIPMENT BECAUSE HE SAYS THAT THERE IS A DELAY AT FEDEX. PLEASE ASSIST. THIS HAPPENED REGULARLY ((B)(6) 2023 HOSPITALIZED). REFERENCE REPORT: MW5145444.