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

Model Number	CQR-S-2U0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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 applied a new patch and her glucose levels returned to normal.The patient did not save the cequr simplicity device but was able to provide the lot number.An investigation of the lot device history record revealed no nonconformities or deviation related to the nature of the complaint.

• Brand Name: CEQUR SIMPLICITY
• Common Device Name: Pump, infusion, insulin bolus
• Manufacturer (Section D): CEQUR SA; ebenaustrasse 10; horw luzern, 6048 ; SZ 6048
• MDR Report Key: 24746481
• Report Number: 3015218509-2026-00001
• Device Sequence Number: 8772180
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• Device Model Number: CQR-S-2U0
• Device Lot Number: FT2504991
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown