BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2884771 · Received December 3, 2012

    Report

    Report Number
    2183996-2012-01724
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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

    PT REPORTED THE MENU BUTTON ON THE INFUSION DEVICE IS DIFFICULT TO PRESS BUT CONTINUES TO WORK. THE INFUSION DEVICE WAS REQUESTED FOR EVAL. DURING THE PRELIMINARY INVESTIGATION, A COMPANY REP DETECTED THE MENU BUTTON WORKS INTERMITTENTLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADD'L INFO WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP