BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1903405 · Received November 12, 2010

    Report

    Report Number
    2183996-2010-02298
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 SHE WAS IN THE HOSPITAL WITH ELEVATED BLOOD GLUCOSE ON (B)(6) 2010. PT STATED SHE WAS IN THE HOSPITAL FOR 4 DAYS AND REC'D INSULIN BY INFUSION. PT REPORTED SHE WAS BROUGHT TO THE HOSPITAL IN THE CAR BY HER HUSBAND. PT STATED HER BLOOD GLUCOSE VALUE WAS 40.0 MMOL/L (720 MG/DL). PT REPORTED THE ISSUE BEGAN THAT DAY IN THE MORNING WITH A BLOOD GLUCOSE VALUE OF 15.0 MMOL/L (270 MG/DL). PT STATED SHE TESTED HER BLOOD GLUCOSE EVERY 2 HRS, AND CHANGED THE INFUSION SET. PT'S NORMAL BLOOD GLUCOSE VALUE IS 8-9 MMOL/L (144-162 MG/DL). PT REPORTED SHE GAVE EXTRA BOLUSES OF 10.0 UNITS/HR VIA THE INFUSION DEVICE. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 Hospitalization| O| R INSULIN (DATE OF TX: (B)(6))| (DATE OF TX: (B)(6))| INSULIN INFUSION SET