BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSULIN PUMP

    MDR report key: 5836231 · Received July 27, 2016

    Report

    Report Number
    MW5063757
    Event Type
    Other
    Date Received
    July 27, 2016
    Report Date
    July 27, 2016
    Manufacturer
    UNK
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS BEEN A TYPE 1 DIABETIC SINCE (B)(6). THE DOCTOR STATED HER A1C HAS GONE UP TO 12.6. HER A1C HAS NOT BEEN THAT HIGH SINCE SHE WAS (B)(6). SHE HAD AN INSULIN PUMP FOR TWO YEARS BUT SHE KEPT HAVING COMPLICATIONS WITH IT. THE PATIENT REPORTED HER MACHINE WOULD CONTINUE TO PUMP INSULIN INTO HER BODY AND WOULDN'T STOP. SHE HAD GONE INTO A COMA ON FOUR DIFFERENT OCCASIONS AND HAD TO CALL 911. SHE STATED ONCE HER SUGAR LEVELS HAD REACHED 35 AND ANOTHER TIME HER SUGAR LEVELS DROPPED AS LOW AS 21. IT WOULD HAPPEN WHEN SHE WAS SLEEPING HER CHILDREN WOULD HAVE TO MAKE SURE SHE WOULD BE ABLE TO WAKE UP IN THE MIDDLE OF THE NIGHT, THERE WERE TIMES THAT SHE WOULD BE UNRESPONSIVE AND THEY WOULD HAVE TO CALL 911. SHE HAD ALMOST DIED BECAUSE OF THE INSULIN PUMP AND BECAME VERY SICK, HER SUGAR LEVELS HAD DROPPED DOWN TO 35 AND SHE CONTINUED TO WORK SHE ATE A LITTLE AND HER SUGAR LEVELS HAD INCREASED TO 45. THE PATIENT EVENTUALLY HAD THE INSULIN PUMP REMOVED. SHE IS TAKING HUMALOG TWICE A DAY AT 14 UNITS AND SOMETIMES FORGETS TO TAKE HER MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479974 INSULIN PUMP INSULIN PUMP FRN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR