BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1905764 · Received November 16, 2010

    Report

    Report Number
    2183996-2010-01754
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN 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. THE INFUSION DEVICE WAS THOROUGHLY EVALUATED AND MEETS SPECIFICATIONS. THE DEVICE DELIVERS THE PROGRAMMED AMOUNT OF INSULIN CORRECTLY. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE PATIENT BELIEVES THE INFUSION DEVICE DELIVERS TOO MUCH INSULIN. THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE OF 40 MG/DL. HER NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR INSULIN INFUSION SET| INSULIN