MINI MOBILE MEDTRONIC APP

Description of Event or Problem

MY DAUGHTER'S PHONE UPDATED TO ANDROID OPERATING SYSTEM VERSION 16, THE MEDTRONIC MINIMED MOBILE APP STOPPED WORKING. THE APP IS NOW UNSUPPORTED ON THE BRAND NEW UPDATED PHONE, AND THIS PREVENTS REAL-TIME VIEWING AND SHARING OF INSULIN PUMP AND CONTINUOUS GLUCOSE MONITOR (CGM) DATA. THIS IS A SERIOUS SAFETY ISSUE BECAUSE MY CHILD RELIES ON THIS APP FOR REMOTE GLUCOSE MONITORING DURING SCHOOL HOURS. HER SCHOOL DOES NOT HAVE A NURSE, AND I AM THE ONE RESPONSIBLE FOR MONITORING HER LEVELS REMOTELY THROUGH THE APP. WITHOUT IT, I LOSE VISIBILITY INTO HER GLUCOSE DATA AND PUMP ACTIVITY, WHICH PUTS HER AT RISK FOR BOTH HYPOGLYCEMIA AND HYPERGLYCEMIA. A SIMILAR ISSUE OCCURRED WHEN MY SAMSUNG PHONE FIRST UPDATED TO ANDROID 16; THE CARELINK APP STOPPED WORKING FOR SEVERAL DAYS BEFORE RANDOMLY RESUMING FUNCTIONALITY. NOW, WITH MY CHILD'S NEW PHONE RUNNING ANDROID 16, THE MINIMED MOBILE APP REMAINS INCOMPATIBLE, AND THERE IS NO AVAILABLE FIX OR UPDATE FROM MEDTRONIC. THIS REPEATED LOSS OF FUNCTIONALITY AFTER OS UPDATES IS UNACCEPTABLE FOR A MEDICAL DEVICE APP THAT PATIENTS AND CAREGIVERS RELY ON FOR REAL-TIME SAFETY MONITORING. IMPACT: APP WILL NOT CONNECT TO OR DISPLAY DATA FROM THE INSULIN PUMP/CGM REAL-TIME REMOTE MONITORING COMPLETELY DISABLED PEDIATRIC PATIENT SAFETY RISK DUE TO INABILITY TO MONITOR AT SCHOOL NO ALTERNATIVE VERSION OR PATCH AVAILABLE FROM MEDTRONIC REQUESTED ACTION: PLEASE INVESTIGATE AND PROMPT MEDTRONIC TO RELEASE AN ANDROID 16¿COMPATIBLE UPDATE OR PROVIDE AN IMMEDIATE WORKAROUND FOR AFFECTED USERS. THIS SOFTWARE FAILURE DIRECTLY COMPROMISES THE SAFETY OF PEDIATRIC DIABETES PATIENTS DEPENDENT ON REAL-TIME MONITORING. PT CODE: 4582. DEVICE CODE: 2880. REF REPORT: MW5178710.