BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2202482 · Received August 5, 2011

    Report

    Report Number
    2183996-2011-02161
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 STARTED USING THE INFUSION DEVICE 3 WEEKS PRIOR TO THE REPORT AND EXPERIENCED HYPERGLYCEMIA OF 345 MG/DL AND KETONEMIA OF 1.5 ON (B)(6) 2011. PT ALSO EXPERIENCED SEVERE CEPHALEA. PT ATTEMPTED TO TREAT HYPERGLYCEMIA BY INJECTING 4.5 UNITS OF INSULIN AND WAS THEN REFERRED TO A MED CTR FOR ASSISTANCE. SHE WAS TREATED WITH INTRAVENOUS INSULIN AND SALINE. TWO HOURS AFTER ADMISSION, PT WAS STABLE AND WAS ALLOWED TO LEAVE THE MED CTR AND RETURN HOME. PT WAS MONITORED, AND 12 HOURS AFTER THE FIRST CALL, PT CONTINUED TO HAVE NORMAL BLOOD GLUCOSE. PT HAD AN APPOINTMENT WITH HER ENDOCRINOLOGIST ON (B)(6) 2011, AND THE ENDOCRINOLOGIST CONFIRMED THAT THE INFUSION DEVICE WORKS CORRECTLY AND THAT THE PT IS NOW STABLE. INFUSION DEVICE WAS REQUESTED FOR EVAL. NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R INSULIN INFUSION SET| INSULIN