BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1904052 · Received November 12, 2010

    Report

    Report Number
    2183996-2010-02296
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 19, 2010
    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
    RS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INFUSION DEVICE "DOESN'T DELIVER LOW DOSE OF INSULIN." INFUSION DEVICE WAS REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADD'L INFO WAS AVAILABLE.

    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