Description of Event or Problem · 0
WHILE VISITING A PHYSICIAN'S OFFICE ON (B)(6) 2025, A CEQUR EMPLOYEE WAS INFORMED BY THE PHYSICIAN THAT A PATIENT WHO HAD BEEN PRESCRIBED CEQUR SIMPLICITY HAD BEEN DISCHARGED FROM A HOSPITAL EARLIER IN THE WEEK AFTER AN EPISODE OF DIABETIC KETOACIDOSIS. THE PHYSICIAN SAID THAT SHE WAS UNSURE WHAT ACTUALLY HAPPENED WITH THE DEVICE BUT THAT THE PATIENT TOLD HER "IT HAD TO DO WITH THE NEEDLE". CEQUR MADE AN UNANSWERED CALL TO THE PATIENT TO OBTAIN ADDITIONAL INFORMATION, AFTER WHICH THE PATIENT'S HUSBAND RETURNED THE CALL TO CEQUR. THE HUSBAND REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR A STROKE 1-2 WEEKS EARLIER. AFTER ARRIVING HOME FOLLOWING DISCHARGE FROM THE HOSPITAL, HE STATED THAT HE "PUT THE PATCH ON HER" BUT THAT HER "HER BLOOD SUGARS WERE NOT RETURNING TO NORMAL". HE STATED THAT "THE NEEDLE DIDN'T GO ALL THE WAY IN" AND THAT THE PATIENT SUBSEQUENTLY "WENT INTO DIABETIC KETOACIDOSIS" AND WAS ADMITTED TO THE ICU FOR 3 DAYS, AFTER WHICH THE PATIENT WAS DISCHARGED HOME. THE HUSBAND, WHO WAS NOT PRESENT AT THE PATIENT'S INITIAL OR FIRST PATCH CHANGE TRAINING SESSIONS, STATED THAT HE WOULD LIKE TO BE TRAINED ON HOW TO USE THE PRODUCT. THE HUSBAND STATED THAT THEY DID NOT RETAIN THE DEVICE AND HE WAS UNABLE TO PROVIDE THE LOT NUMBER.