BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1991522 · Received January 28, 2011

    Report

    Report Number
    2183996-2011-00094
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 17, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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

    THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE WHILE USING THE INFUSION DEVICE. THE PATIENT STATES E1 (CARTRIDGE EMPTY) ERROR IS DISPLAYED ON THE INFUSION DEVICE WHEN THE INSULIN CARTRIDGE IS STILL 1/3 FULL. SINCE THE BEGINNING OF (B)(6) 2010 THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF UP TO 20 MMOL/L (360 MG/DL) DESPITE DELIVERING EXTRA BOLUSES AND INCREASING THE BASAL RATE FROM 2.5 U/H TO 4.0 U/H. THE PATIENT'S NORMAL BLOOD GLUCOSE VALUE IS 8-10 MMOL/L (144-180 MG/DL). THE PATIENT'S BLOOD GLUCOSE RETURNED TO NORMAL AFTER SWITCHING TO ANOTHER PUMP. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN