BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2012278 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00464
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 18, 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
    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.

    Description of Event or Problem · 1

    COMPANY VENDOR REPORTED, THE PATIENT HAS EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL UP TO 25 MMOL/L (450 MG/DL). COMPANY VENDOR STATED THAT ON SEVERAL OCCASIONS THE INSULIN CARTRIDGE IS LEAKY ON THE SIDE OF THE CARTRIDGE STOPPER. COMPANY VENDOR REPORTED THE PATIENT CHANGED THE ACCESSORIES AND ADMINISTERED INSULIN VIA PEN AND THE BLOOD GLUCOSE RETURNED TO NORMAL. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 32232760

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR INSULIN| INSULIN INFUSION SET