BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1872034 · Received October 8, 2010

    Report

    Report Number
    2183996-2010-02097
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 30, 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

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

    Description of Event or Problem · 1

    PATIENT REPORTED ELEVATED BLOOD GLUCOSE LEVELS FOR THE PAST 2-3 WEEKS WITH READINGS AROUND 20.0-23.0 MMOL/L (360-414 MG/DL). PATIENT REPORTED CONTACTING THE DIABETES NURSE ON (B)(6) 2010; ADVISED TO USE INJECTIONS. PATIENT IS CURRENTLY IN THE HOSPITAL. PATIENT STATED WHEN HER BLOOD GLUCOSE IS STABLE SHE CAN USE THE INFUSION DEVICE AGAIN. PATIENT REPORTED THE INFUSION DEVICE GAVE A LOT OF E4 (OCCLUSION) ERRORS IN THE LAST FEW WEEKS. PATIENT STATED SHE GAVE HER BOLUSES WITH THE INJECTION PEN. PATIENT REPORTED HAVING A LOT OF STRESS. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    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 35 YR Hospitalization| R INSULIN INFUSION SET| INSULIN