BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC PARADIGM INSULIN PUMP

    MDR report key: 2163522 · Received June 19, 2011

    Report

    Report Number
    MW5021306
    Event Type
    Injury
    Date Received
    June 19, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 19, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR (B)(6) 2011: I HAVE JUST RECEIVED MY ORIGINAL LETTER DATED (B)(6) 2011 THAT WAS SENT BY CERTIFIED MAIL WITH RETURN RECEIPT AFTER THE LETTER HAD BEEN SIGNED FOR BY MEDTRONIC'S AGENT WITHOUT BEING OPENED TO REPORT THE ADVERSE EVENT THAT MY SISTER (B)(6) EXPERIENCED WHILE ON A MEDTRONIC INSULIN PUMP. I HAVE ENCLOSED A COPY OF THE ENVELOPE, THE CERTIFIED MAIL RECEIPT AND THE INFO FROM THE MEDTRONIC WEBSITE ON HOW TO CONTACT YOU VIA U.S MAIL. I AM VERY DISAPPOINTED THAT MY LETTER WAS RETURNED TO ME UNOPENED. HAVING TALKED TO THE TECHNICAL HOTLINE I HAD BEEN TOLD THAT THE ONLY WAY TO RECEIVE A WRITTEN REPLY WAS TO SEND A WRITTEN LETTER. I AM ENCLOSING A COPY OF THE (B)(6) LETTER WITH THE HOPE THAT YOU WILL RESPOND TO THE SUGGESTIONS. IN ADDITION TO MY SISTER (B)(6), I HAVE ALSO BEEN A CUSTOMER OF YOURS FOR ABOUT 10 YEARS. MEDTRONIC IS MY SECOND VENDOR OF THE INSULIN PUMPS I HAVE USED. I CERTAINLY FEEL WITH THE RETURN OF MY LETTER, IN THAT IT WAS ACCEPTED THE MEDTRONIC AGENT AND SENT TO APPROPRIATE ADDRESS, DISCOURAGED WITH THE CUSTOMER SERVICE I RECEIVED. SINCE THIS EVENT WAS REPORTED TO MEDTRONIC SHORTLY AFTER MY SISTER WAS HOSPITALIZED I TRUST THAT YOU MADE THE FIRST CONTACT TO THE FDA AND NOT NOVO NORDISK. THE UNFORTUNATE NEWS IS THAT MY SISTER CONTINUES TO BE IN AN UNRESPONSIVE STATE BECAUSE OF THE HYPOGLYCEMIC EVENT. THANK-YOU IN ADVANCE FOR WRITTEN RESPONSES TO BOTH MY FIRST AND THIS SECOND LETTER.

    Description of Event or Problem · 1

    I AM WRITING TO SHARE SOME VERY UNPLEASANT NEWS. IT IS POSSIBLE THAT MEDTRONIC MAY HAVE ALREADY REPORTED THIS SITUATION TO THE FDA. THIS WAS BASED ON THE SECOND OF TWO CALLS TO THEM CONCERNING MY SISTER, (B)(6), AN INSULIN DEPENDENT, TYPE 1 DIABETIC, ON NOVOLOG INSULIN PROVIDED VIA A MEDTRONIC PARADIGM 523 INSULIN PUMP (B)(4). DURING MY SECOND CALL TO MEDTRONIC WHEN THE NOTES FROM MY FIRST CALL WERE FOUND NOT TO INCLUDE SPECIFIC INFO THAT WOULD HAVE BEEN NEEDED TO MAKE A REPORT TO THE FDA, ALTHOUGH IT HAD BEEN PROVIDED TO MEDTRONIC. ON MY SECOND CALL WE CONFIRMED THAT MY SISTER'S, (B)(6), MINIMED PARADIGM 523 INSULIN PUMP PASSED MEDTRONIC'S MECHANICAL TEST. I ALSO SPOKE WITH NOVO NORDISK DURING THE WEEK OF (B)(6) 2011 TO TRY TO UNDERSTAND THE MEDICAL SITUATION THAT MY SISTER IS IN. FROM DISCUSSIONS WITH THEIR PRODUCT SAFETY GROUP, I BELIEVE THAT THEY HAVE/WILL REPORT TO THE FDA ABOUT THE SITUATION AFTER CONTACTING MY SISTER'S HEALTH CARE PROVIDERS. WITH THIS IN MIND I HAVE CHOSEN TO REPORT TO MEDTRONIC AND COPY THE FDA AND NOVO NORDISK IN WRITING. I WOULD LIKE A WRITTEN RESPONSE FROM MEDTRONIC THAT MY CONCERNS/SUGGESTIONS ARE BEING REVIEWED AND IF NOT I WOULD ALSO LIKE TO KNOW WHY NOT. WE HAVE JUST PASSED THE SIXTH WEEK THAT MY SISTER REMAINS IN AN UNRESPONSIVE STATE FROM A HYPOGLYCEMIC EVENT THAT HAPPENED ON (B)(6) 2011. HER HUSBAND FOUND HER, MID-AFTERNOON, IN THE BEDROOM AND CALLED 911 BECAUSE HE COULD NOT AROUSED HER. THE EMTS WHO ARRIVED REPORTED HER BLOOD GLUCOSE WAS 18 MG/DL. SHE WAS GIVEN GLUCOSE AND TRANSPORTED TO THE LOCAL HOSPITAL. AT THE TIME OF TRANSPORT SHE WAS BREATHING SHALLOWLY. AT THE HOSPITAL SHE WAS GIVEN ADD'L GLUCOSE AND CONTINUED TO REMAIN AN UNRESPONSIVE STATE ALTHOUGH HER BLOOD GLUCOSE REACHED NORMAL LEVELS. WITH HER CONTINUED UNRESPONSIVENESS SHE WAS TRANSPORTED TO A (B)(6) HOSP, (B)(6). THE NEUROLOGISTS AT THE HOSP HAVE TOLD US THE SITUATION IS VERY GRIM - AT THE PRESENT TIME THEY DO NOT EXPECT HER TO RECOVER TO THE (B)(6) THAT WE KNOW BEFORE THIS EVENT AND BELIEVE THAT WE, AS A FAMILY, WILL HAVE TO MAKE A DIFFICULT DECISION IN THE FUTURE. SHE WAS TRANSFERRED TO A REHABILITATION HOSP THAT CAN DEAL WITH PATIENTS ON VENTILATORS IN AN ATTEMPT TO WEAN HER FROM THE VENTILATOR AND BEGIN PHYSICAL THERAPY. SHE HAS BEGUN WHAT THE PULMONOLOGISTS AT (B)(6) ICU HAD TOLD US THAT WE SHOULD EXPECT - THAT SHE WILL RETURN BACK TO AN ICU IN (B)(6) BECAUSE OF THE RISK OF INFECTION OF PATIENTS ON VENTILATORS AND WITH PICC LINES. WE HAVE LOOKED AT THE INFO STORED IN HER PUMP AND BLOOD GLUCOSE METER. ( I AND ANOTHER SISTER ARE BOTH TYPE 1 INSULIN DEPENDENT DIABETICS WHO ARE ON MINIMED PARADIGM INSULIN PUMPS, USING NOVOLOG INSULIN AND USE SIMILAR BLOOD GLUCOSE METERS, SO RETRIEVING AND REVIEWING THE DATA ON HER PUMP AND BLOOD GLUCOSE METER WERE POSSIBLE TO LEARN WHAT HAD HAPPENED). (B)(6) PUMP DID ALARM THAT SHE HAD A LOW BLOOD GLUCOSE OF ABOUT 65 MG/DL BECAUSE SHE WORE A CONTINUOUS GLUCOSE MONITOR (CGM) - SHE TESTED AND THE METER READING AT THAT TIME WAS 34 MG/DL. (B)(6) APPARENTLY TRIED TO TREAT IT WITH JUICE FOUND AT HER BEDSIDE. THE UNFORTUNATE THING IS THAT SHE GAVE HERSELF ADD'L INSULIN VIA THE PUMP; WE ARE IN THE PROCESS OF OBTAINING LEGAL GUARDIANSHIP, SO THAT MEDTRONIC CAN TALK DIRECTLY WITH MY OTHER SISTER ON HOW THIS HAPPENED WITH THE INSULIN PUMP. THIS IS WHERE MY ISSUES WITH THE INSULIN PUMP AND THE TRAINING TO USE THE PUMP NEED TO BE IMPROVED. WITH A LOW BLOOD GLUCOSE CONFUSION AND MENTAL FOGGINESS ARE OFTEN PRESENT. ON THE CURRENT PUP DESIGN THE FIRST ACT OPTION IS BOLUS, WHICH IS TO TAKE ADD'L INSULIN. THE SECOND OPTION ON THE PUMP IS TO SUSPEND THE PUMP WHICH MUST BE CONFIRMED BY A SECOND PRESS OF THE ACT BUTTON. THE CURRENT METHOD REQUIRES ONE TO PUSH THE ACT BUTTON, SCROLL DOWN PASS THE BOLUS OPTION, ON THE SECOND OPTION WHICH IS TO SUSPEND PRESS THE ACT AND THEN PRESS THE ACT BUTTON A SECOND TIME TO CONFIRM THE SUSPEND ACTION. THE PUMP NEEDS TO HAVE SUSPEND AS THE FIRST OPTION WITHOUT A NEED TO CONFIRM THE ACTION. LET THE PUMP ALARM THE USER EVERY 3 MINUTES THAT IT IS IN A SUSPENDED MODE OR GIVE THEM A SCROLL DOWN OPTION TO HAVE THE PUMP ALARM AT A LESS FREQUENT INTERVAL, BUT IN THAT CONFUSED STATE A DIABETIC COULD CEASE TAKING INSULIN BY PUSHING THE ACT BUTTON TWICE TO SELECT SUSPEND INSULIN DELIVERY. A SECOND OPTION WOULD BE TO HAVE A 'KILL SWITCH" ON THE PUMP THAT IF PRESSED SHUTS OFF THE DELIVERY OF INSULIN WITHOUT HAVING TO MESS AROUND WITH MENUS. I ASSUME THAT TO IMPLEMENT EITHER OF THE ABOVE OPTIONS WILL REQUIRE PROGRAMMING/DESIGN WORK BY MEDTRONIC AND PROBABLY FDA APPROVAL FOR THE CHANGES. A THIRD OPTION IS TO CHANGE THE TRAINING ASSOCIATED THE OPERATION OF THE INSULIN PUMP. MY INITIAL TRAINING WAS NOT ON A MEDTRONIC PUMP, AND I RECEIVED DIFFERENT DIRECTIONS FROM MY PUMP TRAINER AND DOCTOR WHO SAID THAT IF MY BLOOD GLUCOSE WAS LOW THE BEST THING WAS TO DISCONNECT THE PUMP FROM MY BODY. IF THE SITUATION DEVELOPED INTO A MEDICAL EMERGENCY WHERE I BECAME UNCONSCIOUS, I WOULD STILL HAVE THE PUMP WITH ME, BUT NOT GIVING ANY INSULIN (AND IN CASE SOMEBODY TRYING TO HELP OR AN EMT ACCIDENTLY CAUSED THE PUMP TO DELIVER INSULIN). EVEN WITH THE SUSPEND OPTION ON MY CURRENT PUMP WITH A LOW BLOOD SUGAR, I STILL FOLLOW MY ORIGINAL TRAINING AND DISCONNECT THE PUMP. THIS IS BY FAR EASIER TO DO RATHER THAN MESS AROUND WITH MENUS. ONCE MY BLOOD GLUCOSE IS HIGH ENOUGH THE ONE THING THAT I DO IS TO RECONNECT THE PUMP. YES, DURING THE TIMES WHEN I HAVE PASSED OUT/BECOME UNRESPONSIVE DURING A HYPOGLYCEMIC EVENT I WOULD IMAGINE THAT A SIMPLE KILL SWITCH ON THE PUMP WOULD BE AN EASIER WAS FOR SOMEBODY - LIKE MY HUSBAND - TO USE TO SHUT OFF THE PUMP. GIVEN THAT AN INSULIN PUMP IS CONSIDERED A MEDICAL DEVICE, I IMAGINE THAT INCORPORATING A KILL SWITCH OR EVEN CHANGING THE ORDER OF THE ACT BUTTONS WOULD REQUIRE FDA APPROVAL. OVER THE PAST 9 NINE YRS I HAVE RECEIVED 2 LETTERS FROM MEDTRONIC CONCERNING THEIR INSULIN PUMPS AND ACTIONS REQUIRED OF USERS. WHEN I PURCHASED MY FIRST PUMP IT WAS SUPPOSED TO BE WATERPROOF - MEDTRONIC ISSUED A LETTER TO PUMP WEARS THAT BECAUSE SMALL CRACKS THAT COULD DEVELOP IN THE PUMP CASING, THE PUMPS WERE NO LONGER CONSIDERED WATERPROOF AND SHOULD NOT BE USED IN THE WATER UNDER ANY CIRCUMSTANCES. THE SECOND LETTER I RECEIVED FROM MEDTRONIC CONCERNING THE PUMP WAS THE STEPS TO GO THROUGH, SO THAT WHEN THE ONE TOUCH ULTRALINK BLOOD GLUCOSE METER WAS USED THAT IT WOULD NOT TRIGGER AN AUTOMATIC CALIBRATION OF THE CGM (CONTINUOUS GLUCOSE MONITOR). PRIOR TO PURCHASING THE CGM TO USE WITH MY MEDTRONIC INSULIN PUMP, BOTH MEDTRONIC AND MY MEDTRONIC TRAINER KNEW I WAS TESTING MY BLOOD GLUCOSE LEVELS UP TO 10/DAY. IT BECAME A KNOWN ISSUE THAT 10 CALIBRATION/DAY WILL CAUSE ISSUES WITH THE CGM. THE CURRENT RECOMMENDATION IS A MINIMUM OF 2 UP TO 3 OR 4 CALIBRATIONS/DAY. I WOULD THINK A LETTER RECOMMENDING USERS DISCONNECT THE PUMP COULD BE APPROPRIATE WHEN TREATING LOW BLOOD SUGARS BECAUSE THE TIME BETWEEN CONSCIOUS AND UNCONSCIOUS IS NOT AN EXACT BLOOD GLUCOSE READING AND IF IT IS THE ONLY THING ONE DOES, IT MAY PREVENT WHAT HAPPENED TO MY SISTER. WE AS A FAMILY ARE HEARTBROKEN ABOUT (B)(6) CURRENT SITUATION. I KNOW THAT HER ENDOCRINOLOGIST FEELS BAD ABOUT THE EVENT AS WELL. I WOULD LIKE TO SEE SOMETHING DONE TO PROTECT OTHER USERS OF THIS INSULIN PUMP, IF NOT ADD'L INSULIN PUMPS. AS I MENTIONED A THE BEGINNING, I WOULD LIKE TO KNOW WHAT, IF ANYTHING, MEDTRONIC IS CONSIDERING FOR THE FUTURE OF THE MINIMED PARADIGM INSULIN PUMPS. THANK-YOU IN ADVANCE FOR A RESPONSE TO THIS LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PARADIGM INSULIN PUMP INSULIN PUMP MDS MEDTRONIC 523

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVOLOG INSULIN / NOVO NORDISK, INC.