BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IACCU-CHEK SPIRIT COMBO

    MDR report key: 2820329 · Received October 31, 2012

    Report

    Report Number
    2183996-2012-01670
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE OF 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

    PATIENT REPORTED SHE NEEDS HIGH EFFORT TO PRESS THE MENU BUTTON ON THE INFUSION DEVICE. PATIENT STATED THE BUTTON IS FUNCTIONAL. PRELIMINARY RESULTS SHOW THE MENU BUTTON IS FUNCTION BUT TAKES HIGH EFFORT TO PRESS IT. NO FURTHER INFORMATION AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN