BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1241801 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01756
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 19, 2008
    Report Date
    October 21, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT TWO NIGHTS AGO HER INSULIN INFUSION DEVICE GAVE AN E7 (ELECTRONIC ERROR) MESSAGE WHILE SHE WAS SLEEPING. SHE STATED WHEN SHE REALIZED IT WAS AN E7, SHE REMOVED THE DEVICE BATTERY AND SWITCHED TO INJECTION THERAPY. WHILE ON INJECTIONS, SHE STATED SHE HAD AN ELEVATED BLOOD GLUCOSE READING THIS MORNING OF 404 MG/DL WITH HER NORMAL RANGE BEING IN THE 200'S MG/DL. SHE STATED SHE INJECTED 50 UNITS OF INSULIN AND, BECAUSE SHE FELT SLEEPY, WENT TO BED. SHE SAID SHE HAD JUST WOKEN UP AND HAD NOT CHECKED HER READINGS ALL DAY. THE PATIENT CHECKED HER BLOOD GLUCOSE WHILE ON THE CALL AND HER READING WAS 507MG/DL. THE PATIENT STATED SHE CALCULATED HER BOLUS TO BE 12 UNITS OF INSULIN BUT SHE STATED SHE WAS GOING TO TAKE ANOTHER 50 UNITS. TO TROUBLESHOOT HER INFUSION DEVICE, THE PATIENT REMOVED THE BATTERY AND LEFT IT OUT FOR 3 MINS BEFORE RE-INSERTING IT. HER DEVICE GAVE AN E7. THE PATIENT WAS ADVISED TO LEAVE THE BATTERY OUT FOR ONE HOUR BEFORE RE-INSERTING THE BATTERY AND IF SHE RECEIVED ANOTHER E7 TO LEAVE THE BATTERY OUT FOR 1 HOUR BEFORE RE-INSERTING THE BATTERY AND IF SHE RECEIVED ANOTHER E7 TO LEAVE THE BATTERY OUT FOR 6 HOURS. THE PATIENT WAS ASSISTED WITH SUCCESSFULLY PROGRAMMING HER BACKUP INFUSION DEVICE. ON FOLLOW UP WITH THE PATIENT THE NEXT DAY, SHE STATED SHE WENT TO THE DOCTOR TODAY AND HE ADJUSTED HER BASAL RATES. SHE STATED SHE INSERTED THE BATTERY LAST NIGHT AT 9:10PM AND RECEIVED AN E7. SHE THEN LEFT THE BATTERY OUT OF 6 HOURS BEFORE RE-INSERTING IT AND AGAIN RECEIVED AN E7 MESSAGE. SHE STATED SHE WORE HER INFUSION DEVICE THROUGH AIRPORT SECURITY SEVEN MONTHS PRIOR. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R INSULIN| INSULIN INFUSION SET