CONTROL IQ SOFTWARE (FOR TANDEM DIABETES PUMPS)

Description of Event or Problem

TANDEM DIABETES PUMP #90649752 USING TANDEM CONTROL IQ SOFTWARE FIRMWARE 2.27.2.103, HARDWARE REVISION 0XFF, BLE HARDWARE ID 16705, SOFTWARE NUMBER (B)(4). CONTROL IQ SOFTWARE PREDICTED A BLOOD SUGAR TO EXCEED 180 MG/DL AND DELIVERED A CORRECTED BOLUS OF INSULIN (NOVOLOG). THE PROBLEM OCCURRED WHEN THE GLUCOSE LEVEL BEGIN TO DROP BEFORE THE INSULIN WAS DELIVERED; AND THE RESULTING BOLUS RESULTED IN A RAPIDLY FALLING BLOOD SUGAR WHICH FELL TO 57 MG/DL BEFORE CORRECTIVE ACTION COULD BE TAKEN. THIS PROBLEM WITH THE CONTROL IQ SOFTWARE HAS HAPPENED AT LEAST 5 TIMES SINCE (B)(6) 2022. LOW BLOOD SUGAR WAS CONFIRMED WITH FINGER STICK BLOOD GLUCOSE. FDA SAFETY REPORT ID# (B)(4).