BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2190332 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02117
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE WAS HOSPITALIZED ON (B)(6) 2011 FOR 1 DAY DUE TO KETOACIDOSIS. BLOOD GLUCOSE LEVELS WERE BETWEEN 154-384 MG/DL, AND PT EXPERIENCED DIFFICULTY BREATHING, WEAKNESS, SWEATING, CONTRACTIONS, AND A STOMACH ACHE. PT IS (B)(6) PREGNANT. PHYSICIAN DELIVERED CORRECTION BOLUSES THROUGH THE INFUSION DEVICE EVERY HOUR, AND BLOOD GLUCOSE RETURNED TO HER NORMAL RANGE. PHYSICIAN ALSO ADJUSTED THE BASAL RATES ON THE INFUSION DEVICE. AT THE TIME OF THE REPORT, PT'S BLOOD GLUCOSE LEVELS WERE NORMAL AND HER HEALTH WAS FINE. PT BELIEVES THE INFUSION DEVICE DOES NOT DELIVER INSULIN CORRECTLY. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R INSULIN (DATE OF TX (B)(6))| (DATE OF TX (B)(6))| INSULIN INFUSION SET