Description of Event or Problem · 1
I HAVE EXPERIENCED TWO FAILURES OF THE INSULENT OMNIPOD INSULIN PUMP IN THE LAST 24 HOURS. FIRST, THE POD WHICH I HAD ACTIVATED APPROX 36 HOURS PREVIOUSLY, FAILED DURING NORMAL OPERATION (NON BOLUS). WHEN THE FAILURE OCCURRED, THE PDM LISTED IT AS A "POD ERROR" WITH AN ERROR CODE 19-13600-00051-016. I REPLACED THIS POD WITH A NEW ONE. THE NEW ONE FAILED 8 HOURS LATER DURING A BOLUS. DURING THOSE 8 HOURS, MY BLOOD GLUCOSE HAD RISEN TWICE ABOVE 350MG/DL. BOTH TIMES, I WAS ABLE TO CORRECT IT. THE SECOND FAILURE WAS ALSO LISTED AS A POD ERROR, AND THE ERROR CODE WAS 19-05613-02951-104. I REPORTED BOTH FAILURES TO THE MANUFACTURER. THE MANUFACTURER PROMISED TO REPLACE BOTH AND SEND THE DEFECTIVE PODS BACK TO TESTING, WHICH I WILL DO. EDITORIAL NOTE: SINCE I BEGAN USING THE SMALLER POD IN (B)(6) 2013, I HAVE EXPERIENCED EIGHT FAILURES, AN AVERAGE FAILURE RATE OF 10%. FROM WHAT I HAVE READ ON VARIOUS DISCUSSION BOARDS AND ON THE FDA SITE, I AM NOT ALONE IN EXPERIENCING HIGH FAILURE RATES OF THE OMNIPOD PRODUCT. I ALSO GATHER THAT NO SERIOUS INJURIES OR FATALITIES HAVE RESULTED AS A RESULT OF A POD FAILURE. MY QUESTION IS, HOW LONG BEFORE SUCH A THING HAPPENED? I UNDERSTAND THAT THE MANUFACTURER LOOKS AT THEIR LOT QUALIFICATIONS, ETC FOR EACH EVENT, BUT ANY FIRST YEAR STATISTICIAN COULD TELL YOU THAT THE CRITERIA IN USE MUST BE INADEQUATE FOR SUCH HIGH FAILURE RATES TO OCCUR. I ASK THAT YOU TAKE A CLOSER LOOK AT THE MANUFACTURER'S PROCEDURES AND TIGHTEN UP WHERE NEEDED. THANK YOU.