QUICK SET

Description of Event or Problem

REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER QUANTITY. IT WAS REPORTED THAT PATIENT FACED INSULIN FLOE BLOCK ALARM EVENT ON (B)(6) 2026 CAUSED BY THE BENT CANNULA DUE TO LACK OF ADIPOSE TISSUE. PATIENT GOT HOSPITALIZED DUE DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVEL WAS 223 MG/DL. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

Additional Manufacturer Narrative

INITIAL AND FINAL MDR (B)(4). DEVICE 1 OF 2. SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TREND PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.