Description of Event or Problem · 0
I AM AN INSULIN-DEPENDENT DIABETIC. I USE A MINIMED 7800 INSULIN PUMP. THE PUMP READS A SENSOR ATTACHED TO THE BACK OF THE ARM. SINCE (B)(6), THEY HAVE BEEN ROLLING OUT A NEW EXTENDED-WEAR SENSOR, THE MINIMED INSTINCT MADE BY ABBOTT. I HAVE BEEN USING THE INSTINCT SENSOR FOR ABOUT A MONTH NOW. IT IS UNACCEPTABLY INACCURATE. I KNOW THAT MY ACCUCHECK GUIDE FINGER-STICK METER IS ACCURATE BECAUSE I COMPARE IT WITH MY LAB RESULTS AT LEAST 4 TIMES PER YEAR. THE MANUFACTURER CLAIMS THAT A 20% VARIANCE IS WITHIN ACCEPTABLE LIMITS. PROBLEM 1 IS WILD SWINGS WITHIN A SHORT PERIOD OF TIME. A CHANGE OF 40 POINTS IN 20 MINUTES IS CERTAINLY NOT ABNORMAL WITH THE INSTINCT SENSOR. ON 3/10, IT WENT FROM READING 153 TO READING 55 IN THE SPACE OF 30 MINUTES, A SWING OF 98 POINTS. ON THE MORNING OF (B)(6), I WAS AWAKENED BY A LOW SUGAR READING ALARM CLAIMING THAT I WAS AT 71. I DID NOTHING BECAUSE I WAS MOSTLY CERTAIN THAT IT WAS AN INCORRECT READING. I AROSE FOR THE MORNING ABOUT 20 MINUTES LATER AND IT READ 113. THERE IS NO WAY THAT MY BLOOD SUGAR INCREASED WHILE OVERNIGHT FASTING BY 42 POINTS IN 20 MINUTES. PROPERLY ADMINISTERING BOLUSES OF SUPPLEMENTAL INSULIN VIA THE PUMP IN ORDER TO ADDRESS HIGH INSULIN LEVELS REQUIRES ACCURATE READINGS. TAKING ON ADDITIONAL SUGARS TO "RESCUE" FROM LOW BLOOD SUGAR LIKEWISE REQUIRES ACCURATE READINGS. THERE IS NO THERAPEUTIC VALUE FROM SUCH WILDLY INACCURATE READINGS. FOR THE RECORD, I DID NOT EXPERIENCE THESE WILD SWINGS OVER A SHORT TIME WITH THE OLD-STYLE SENSORS, AND I INTEND TO DISCONTINUE THE INSTINCT SENSORS IN FAVOR OF THE OLD STYLE JUST AS SOON AS I AM ALLOWED TO REORDER SENSORS. PROBLEM 2 IS FAILURE TO STAY CONNECTED TO THE PUMP. MULTIPLE TIMES PER DAY THE PUMP ALARMS THAT IT HAS LOST CONTACT WITH THE SENSOR. IT USUALLY TAKES SEVERAL MINUTES OR MORE TO REESTABLISH A CONNECTION. THIS IS DANGEROUS IF I AM TRENDING LOW AND DO NOT KNOW WHETHER TO INGEST RESCUE SUGAR. PROBLEM 3 IS INSERTION FAILURE. THE SENSOR HAS A TWIST-OFF CAP. WHEN TWISTING OFF THE CAP, IT BRIEFLY GOT STUCK. THE SENSOR PORTION FLEW ONTO THE FLOOR AND THE INSERTION NEEDLE DISPATCHED. AS A RESULT, I WAS REQUIRED TO THROW OUT AN UNUSED SENSOR. I COULD CALL MEDTRONIC TO REQUEST A REPLACEMENT, BUT THE HOLD TIMES REACH 6 1/2 HOURS OR MORE. THE LOT NUMBER ON THE INSTINCT BOX IS T60003640. THE SN (B)(6).