BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1905747 · Received November 16, 2010

    Report

    Report Number
    2183996-2010-02337
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 28, 2010
    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
    GM
    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. THE INFUSION DEVICE WAS THOROUGHLY EVALUATED AND MEETS SPECIFICATIONS. THE DEVICE DELIVERS THE PROGRAMMED AMOUNT OF INSULIN CORRECTLY. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING FREQUENT E4 (OCCLUSION) ERRORS ON THE INFUSION DEVICE. HE SWITCHED TO A DIFFERENT TYPE OF INFUSION SET AND THE FREQUENCY OF E4 ERRORS WAS LESS OFTEN. HE THEN RECEIVED AN E4 DURING THE NIGHT AND WAS UNABLE TO CLEAR THE ERROR. HE DID NOT HAVE AN ALTERNATE FORM OF INSULIN THERAPY AND HE WENT TO THE HOSPITAL FOR TREATMENT. HE WAS TREATED WITH AN INSULIN INJECTION. THE PATIENT'S BLOOD GLUCOSE VALUES WERE NOT PROVIDED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 Hospitalization| R INSULIN INFUSION SET| INSULIN