BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM

    MDR report key: 2025236 · Received March 15, 2011

    Report

    Report Number
    MW5019839
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SENSOR SYSTEM BY MEDTRONIC MINIMED IS BOTH INACCURATE AND UNRELIABLE. I CALLED AGAIN TODAY TO CUSTOMER SERVICE AND ALL I WAS TOLD WAS TO RESTART MY SENSOR. THIS WAS THE SECOND TIME I CALLED THEM WITH THE OTHER JUST 2 DAYS AGO WITH A DIFFERENT SENSOR. I HAVE CALLED MANY TIMES BEFORE AND FIND IT HAS BEEN OFF BY MORE THAN 100% AT TIMES. I REALLY ONLY USE IT AS AN ALARM TO MAKE SURE I WAKE UP IF MY BS GOES TOO LOW. I LIVE ALONE SO THERE IS NO ONE TO CHECK ON ME. THIS MORNING, I GOT NO ALARM BECAUSE IT SAID MY BS WAS 106. MY CAT ACTUALLY WOKE ME UP AND A FINGER STICK SAID MY BS WAS CLOSER TO 53 AT 6:30 AM. FIRST I DRANK REGULAR SODA TO BRING MY BS UP. THEN I TESTED MY METER AND IT PASSED THE TEST. SO I DEDUCED IT WAS MY SENSOR SYSTEM. I UNDERSTAND THERE WILL BE A DIFFERENCE BETWEEN A FINGER STICK AND THE SENSOR READINGS, BUT THIS MAKES THE SYSTEM USELESS. SOMETIMES THE SENSOR WARNS ME MY BS IS LOW AND AGAIN I TEST AND THE SENSOR COULDN'T BE FARTHER FROM REALITY SINCE IT WAS ON THE BORDER OF BEING HIGH. I HAVE MET OTHERS ON THE BUS THAT HAVE GIVEN UP ON THE MINIMED SYSTEM BECAUSE IT CRIES WOLF TOO OFTEN OR DOESN'T CRY AT ALL. ON A RECENT WEB SEMINAR LED BY (B)(6), I FOUND OUT THERE ARE OTHER SYSTEMS -PARTICULARLY THE DEX SYSTEM- THAT ARE FAR MORE ACCURATE AND RELIABLE AND LOTS CHEAPER. THE MINIMED SENSORS ARE OVER (B)(6) EACH AND ALTHOUGH I DON'T HAVE EXACT FIGURES, THE OTHERS ARE A LOT CHEAPER. THEIR CUSTOMER SERVICE HAS GOTTEN A LOT WORSE ALSO LATELY. THEY NEVER EVEN ASKED ME TO TEST THE TRANSMITTER OR MY PUMP, JUST RE-START THE SENSOR. ALTHOUGH TODAY THEY WERE PRETTY QUICK ANSWERING A SERVICE CALL, LATELY THE WAIT HAS BEEN ENORMOUS. THE OTHER DAY THEY ACTUALLY INSTITUTED A SYSTEM THAT CALLED ME BACK INSTEAD OF WAITING ON MY CELL PHONE. ACCU-CHEK, WHICH MAKE MY METER, ALWAYS ANSWER RIGHT AWAY. THERE ARE OTHER PROBLEMS SINCE MEDTRONIC TOOK OVER MINIMED. THEY ARE MORE CONCERNED NOW WITH THEIR BOTTOM LINE THAN THE QUALITY OF THEIR PRODUCT AND IT SHOWS TIME AND TIME AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM SOF-SENSOR MDS MEDTRONIC MINIMED MMT-7707NA A000187983

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| O