INSULIN PUMP CONTROL DEVICE (PDM)

Description of Event or Problem

INSULIN DISPENSED UNDER THE AUTOMATION MODE OF INSULET'S OMNIPOD 5 INSULIN PUMP IS NOT ACCOUNTED IN THE INSULIN ON BOARD TALLY THAT IS PROVIDED BY THE INSULIN PUMP CONTROL DEVICE (PDM) WHICH IS ALSO AN INSULET MANUFACTURED MEDICAL DEVICE AND IS A SEPARATE DEVICE FROM THE OMNIPOD INSULIN PUMP POD. THE INSULIN ON BOARD TALLY IS RELIED UPON BY THE INSULIN PUMP OPERATOR TO DETERMINE APPROPRIATE INSULIN BOLUS DOSAGE WHEN A BOLUS IS NEEDED FOR MEALS OR HIGH GLUCOSE LEVEL CORRECTION. IN MY EPISODE, THE PUMP HAD DISPENSED NEARLY 3 UNITS OF INSULIN OVER THE COURSE OF AN HOUR ACROSS 5 MINUTE INCREMENTS. THIS WAS NOT REFLECTED IN THE INSULIN ON BOARD TALLY. SO UPON BEING WOKEN BY A HIGH GLUCOSE ALARM, I ORDERED THE PDM TO BOLUS A DOSAGE OF INSULIN RELYING ON THE INSULIN ON BOARD TALLY VERSUS THE CURRENT GLUCOSE STATUS. THE BOLUS PLUS THE EXISTING INSULIN FROM THE PUMPS AUTOMATION IN MY SYSTEM WAS TOO MUCH AND I WAS AWOKEN LATER IN THE EVENING WITH A LOW GLUCOSE ALARM FINDING THAT MY GLUCOSE WAS QUICKLY DROPPING BELOW 47.