BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2896378 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01931
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    December 3, 2012
    Report Date
    March 11, 2013
    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
    SW
    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE MENU BUTTON DOES NOT RESPOND. THERE ARE PARTICLES INSIDE THE HOUSING OF THE MENU BUTTON, AND THESE PARTICLES TEMPORARILY ISOLATE THE AREA OF CONTACT INSIDE THE BUTTON HOUSING. DUE TO THIS PROBLEM, THE MENU BUTTON DOES NOT RESPOND AND IS WITHOUT FUNCTION.

    Description of Event or Problem · 1

    COMPANY REP REPORTED ALL OF THE BUTTONS ON THE INFUSION DEVICE ARE NON-FUNCTIONAL. THIS WAS NOTICED DURING THE START-UP OF THE INFUSION DEVICE. THE INFUSION DEVICE WAS REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP