CeQur Simplicity CQR-S-2U01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00373108000006), received between Jun 13, 2025 and Mar 31, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT NOTIFIED A CEQUR EMPLOYEE ON 02MAR2026 THAT WHILE WEARING A CEQUR SIMPLICITY DEVICE, SHE EXPERIENCED HYPOGLYCEMIA. THE PATIENT REPORTED THAT AFTER APPLYING A NEW DEVICE IN THE EVENING ON (B)(6) 2026, AROUND 3:00 AM THE NEXT MORNING, HER CONTINUOUS GLUCOSE MONITOR DISPLAYED GLUCOSE LEVELS BETWEEN 47 AND 52 MG/DL. THE PATIENT CONSUMED SIX CRACKERS, AND HER GLUCOSE LEVELS ROSE, BUT THE CONTINUOUS GLUCOSE MONITOR'S ALARM CONTINUED TO WAKE HER UP THROUGH THE REST OF THE MORNING. THE PATIENT REPORTED THAT HER GLUCOSE LEVEL WAS 67 MG/DL BEFORE BREAKFAST AND THAT SHE ADMINISTERED FOUR UNITS OF INSULIN WITH BREAKFAST. HER CONTINUOUS GLUCOSE MONITOR'S ALARM SOUNDED AGAIN, SO SHE CONSUMED COTTON CANDY IN AN ATTEMPT TO RAISE HER GLUCOSE LEVELS. BEFORE LUNCH, HER GLUCOSE LEVEL WAS 72 MG/DL. SHE ATE BUT DID NOT DOSE INSULIN USING THE DEVICE. THE PATIENT STATED THAT HER GLUCOSE LEVELS WENT DOWN TO 52 MG/DL. SHE SUBSEQUENTLY REMOVED THE SIMPLICITY DEVICE AROUND 2:00 PM. WHEN SHE REMOVED THE DEVICE, SHE NOTICED THAT THE LOCATION WHERE THE PATCH WAS APPLIED WAS WET. SHE ALSO STATED THAT INSULIN "WAS DRIPPING FROM THE END OF THE CANNULA WITHOUT ANY BUTTONS BEING PRESSED." THE PATIENT APPLIE

  Patient problems: Hypoglycemia

  MAUDE report 24746481 ↗
• InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 RE

  Patient problems: Hyperglycemia

  MAUDE report 22206666 ↗