BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1833147 · Received September 9, 2010

    Report

    Report Number
    2183996-2010-01868
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 26, 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
    IT
    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 THAT THE INFUSION DEVICE DOES NOT CORRECTLY DELIVER INSULIN. SHE STATED THAT FOR THE PAST 10-15 DAYS, HER BLOOD GLUCOSE HAS BEEN ELEVATED TO 350-390 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 160-180 MG/DL. SHE CHANGED ALL OF THE ACCESSORIES AND WAS UNABLE TO LOWER HER BLOOD GLUCOSE. SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE RETURNED TO NORMAL. 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| INSULIN INFUSION SET