Description of Event or Problem · 1
MODEL 515 WITH A NEW FEATURE CALLED THE BOLUS WIZARD. THE PROGRAMMING FOR THIS NEW FEATURE IS SEVERELY DEFICIENT UNDER CERTAIN CIRCUMSTANCES, WHICH CAN RESULT IN EXCESSIVE INSULIN DOSAGES. THE BOLUS WIZARD HAS AN ODD AND DOCUMENTED FEATURE TAHT EXCLUDES FROM INSULIN DOSAGE RECOMMENDATION ALL "ACTIVE" INSULIN IF ONE'S BLOOD SUGAR TRIGGERS A "CORRECTIVE BOLUS" AND WHEN THE PT INPUTS ANY NUMBER OF CARBS FOR "FOOD." AS AN EXAMPLE, ONE BLOOD GLUCOSE IS "200", THE AMOUNT OF FOOD TO BE CONSUMED SHORTLY IS INPUT AS 50 CARBS. ACTIVE INSULIN IS "6.OU. IF THE PT HAS A TARGET RANGE OF 100-100, SENSITIVITY OF 25, A CARB RATIO OF 10, THEN THE WIZARD WOULD INDICATE THE FOLLOWING VALUES: ESTIMATED BOLUS: 5.OU, FOOD: 50 CARBS, CORRECTION: 4.0 AND ACTIVE INSULIN: 6.OU, BY DESIGN THE WIZARD WILL SUGGEST THAT THE PT TAKE 5.OU BOLUS BECAUSE WHENEVER THE ACTIVE INSULIN VALUE IS GREATER THAN THE CORRECTION AMOUNT, IT WILL DISCARD BOTH VALUES FROM THE CALCULATION, AND SUGGEST TAKING THE FULL AMOUNT TO COVER THE CARBS; IN THIS EXAMPLE, 5.OU. THAT IS DANGEROUS. THE SELLING FEATURE OF THIS PUMP IS THAT IT PREVENTS INSULIN "STACKING" ACCORDING TO THEIR LITERATURE AND OWNER'S MANUAL. THE REALITY IS THAT THE OPERATING PARAMETERS OF THE BOLUS WIZARD DO EXACTLY THE OPPOSITE WHEN THE CONDITIONS DESCRIBED ARE PRESENT. SOME OTHER DETAILS RPTR HAS NOT MENTIONED ARE THAT THE USER MUST SET THE LENGTH OF TIME THAT INSULIN REMAINS ACTIVE IN THEIR BODY. MINIMED'S 515 PUMP SOFTWARE ALLOWS THE PT TO SET THAT VALVE IN ONE HOUR INCREMENTS IN THE RANGE OF 2 TO 8 HOURS. REGARDLESS OF THE NUMBER OF HOURS SET, THE SENSITIVITY, OR THE CARB RATIO, THE DEFECT EXISTS IN THE LOGIC OF THE BOLUS WIZARD. PERSONALLY, RPTR WAS AFFECTED ADVERSELY BY BECOMING HYPOGLYCEMIC WITHIN TWO HOURS OF TAKING A BOLUS AS SUGGESTED BY THE BOLUS WIZARD. RPTR STRUGGLED FOR APPROX 30 MINUTES TO GET BLOOD GLUCOSE UP FROM A LOW OF 56. BOLUS WIZARD WILL CORRECTLY COMPUTE THE BOLUS IF THE ACTIVE INSULIN VALUE DOESN'T EXCEED THE CORRECTION BOLUS. IT WILL ALSO WORK CORRECTLY WHEN THE PT IS NOT ABOVE THEIR TARGET GLUCOSE LEVEL, BECAUSE THEN THERE IS NO CORRECTION BOLUS. THE VERY FACT THAT THIS PUMP RECEIVED APPROVAL FROM THE FDA LEADS RPTR TO WONDER IF THERE WAS CAREFUL REVIEW OF THIS FEATURE BY SOMEONE INTIMATELY FAMILIAR WITH THE DYNAMICS OF INSULIN THERAPY. RPTR IS CONSIDERING TAKING ADDITIONAL MEASURES IF THIS PROBLEM IS NOT ADDRESSED. BEAR IN MIND THAT THOSE PTS WHO ARE NOT AS FAMILIAR WITH INSULIN PUMP THERAPY SUCH AS RPTR ARE AT GREAT RISK FOR SEVERE INSULIN SHOCK IF THEY FOLLOW THE RECOMMENDATION OF THE BOLUS WIZARD. IT IS IMPORTANT FOR THE PUBLIC'S SAFETY THAT THIS DEFICIENCY BE BROUGHT TO THE ATTENTION OF ALL MINIMED CUSTOMERS EITHER USING THE TWO PUMPS WITH THAT FEATURE MODELS 515 AND 715- OR THOSE CUSTOMERS WHO ARE CONTEMPLATING PURCHASING EITHER MODEL. RPTR WANTS TO REITERATE THAT IF THERE IS NO CORRECTIVE BOLUS REQUIRED, THEN THE WIZARD COMPUTES THE PROPER BOLUS. IF THE PT DOES NOT INPUT ANY FOOD CARBS INTO THE WIZARD, IT ALSO WILL COMPUTE THE PROPER BOLUS. THE ONLY TIME THERE IS A DANGER IS WHEN THE ACTIVE INSULIN VALUE IS HIGHER THAN THE CORRECTIVE BOLUS AND CARBS ARE GREATER THAN ZERO.