MAUDE Adverse Event Report: CEQUR SA CEQUR SIMPLICITY; Pump, infusion, insulin bolus

Model Number	CQR-S-2U01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: CEQUR SIMPLICITY
• Common Device Name: Pump, infusion, insulin bolus
• Manufacturer (Section D): CEQUR SA; ebenaustrasse 10; horw luzern, CH 60 48; SZ CH 6048
• MDR Report Key: 22206666
• Report Number: 3015218509-2025-00002
• Device Sequence Number: 18053483
• Product Code: OPP
• UDI-Device Identifier: 00373108000006
• UDI-Public: 00373108000006
• Combination Product (Y/N): N
• PMA/510(K) Number: K233447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CQR-S-2U01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown