BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2792189 · Received October 11, 2012

    Report

    Report Number
    2183996-2012-01545
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, WIFE REPORTED THE PT RECEIVED TREATMENT AT THE EMERGENCY ROOM ON (B)(6) 2012. THE INFUSION DEVICE HAD DISPLAYED AN E7 ELECTRONIC ERROR EARLIER IN THE DAY, BUT HE WAS ABLE TO CLEAR THE ERROR MESSAGE BY FOLLOWING THE TROUBLESHOOTING STEPS. HIS BLOOD GLUCOSE THEN ELEVATED TO 598 MG/DL, AND HE INSPECTED THE INFUSION DEVICE AND REPORTED THE CARTRIDGE VOLUME HAD NOT CHANGED ALL DAY. THE INFUSION DEVICE WAS IN THE RUN MODE BUT IT DID NOT APPEAR TO BE DELIVERING INSULIN CORRECTLY. HE ATTEMPTED TO BOLUS, AND THE INFUSION DEVICE DISPLAYED ANOTHER E7 ELECTRONIC ERROR. HE INSERTED 3 NEW BATTERIES BUT WAS UNABLE TO CLEAR THE ERROR MESSAGE. HE DELIVERED A 40.0 UNIT INSULIN INJECTION AND WENT TO THE HOSPITAL AROUND 9:15 P.M. AFTER HIS BLOOD GLUCOSE DID NOT DECREASE. HE RECEIVED 2 IV BAGS OF SODIUM CHLORIDE AND A 10.0 UNIT INSULIN INJECTION AFTER HE ATE. HE LEFT THE HOSPITAL AROUND 2:00 AM AFTER HIS BLOOD GLUCOSE RETURNED TO HIS NORMAL RANGE OF 80-120 MG/DL. PT STARTED HIS BACKUP INFUSION DEVICE WHEN HE GOT HOME AND IMMEDIATELY NOTICED IT WAS WORKING CORRECTLY. PT REPORTED THE IV WAS USED AS PRECAUTIONARY MEASURE BECAUSE THE HOSPITAL BELIEVED HE HAD DELIVERED TOO MUCH INSULIN. THE INFUSION DEVICE, BATTERY, ADAPTER, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP