BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1726582 · Received June 14, 2010

    Report

    Report Number
    2183996-2010-01249
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    June 5, 2010
    Report Date
    June 7, 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
    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

    ON (B) (6) 2010, PATIENT REPORTED HE RECEIVED ELEVATED BLOOD GLUCOSE READINGS ON (B) (6) 2010, RANGING FROM 251-390 MG/DL; TOOK CORRECTION DOSE OF INSULIN AFTER EACH READING VIA HIS INFUSION DEVICE. PATIENT STATED HE CHANGED THE INSULIN CARTRIDGE AND NOTICED THERE WAS INSULIN IN THE CARTRIDGE COMPARTMENT. PATIENT REPORTED HE CLEANED THE INFUSION DEVICE AND INSTALLED A NEW INSULIN CARTRIDGE IN THE CARTRIDGE COMPARTMENT. 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 SUSPECT PRODUCT 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 21 YR Required Intervention INSULIN| INSULIN INFUSION SET