BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1911323 · Received November 23, 2010

    Report

    Report Number
    2183996-2010-02466
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 18, 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

    THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 22-24 MMOL/L (396-432 MG/DL) SINCE (B)(6) 2010. THE INFUSION TUBING HAD BEEN IN USE FOR 2 WEEKS AND SHE WAS ADVISED TO CHANGE THE INFUSION TUBING EVERY 4-5 DAYS. SHE CHANGED THE INFUSION SET AND THE NEXT DAY, HER BLOOD GLUCOSE RETURNED TO NORMAL. ON (B)(6) 2010, SHE REPORTED HER BLOOD GLUCOSE ELEVATED TO 22 MMOL/L (396 MG/DL) IN THE MORNING, 24 MMOL/L (432 MG/DL) IN THE AFTERNOON, AND 18 MMOL/L (324 MG/DL) IN THE EVENING. SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND SHE HAD NO FURTHER ISSUES. 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 COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET