BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3013368 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00461
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CAN BE VERIFIED. RESULT THE MENU BUTTON WAS TESTED SUCCESSFULLY. THE CHECK BUTTON DOES NOT RESPOND. THERE ARE PARTICLES OF PLASTIC INSIDE THE HOUSING OF THE CHECK BUTTON. THE PARTICLES TEMPORARY ISOLATE THE AREA OF CONTACT INSIDE THE BUTTON HOUSING. DUE TO THIS PROBLEM THE CHECK BUTTON DOES NOT RESPOND AND IS WITHOUT FUNCTION.

    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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THE MENU BUTTON ON THE INFUSION DEVICE SOMETIME DOESN'T WORK. PATIENT STATED THERE ARE NO HEALTH CONCERNS. NO FURTHER INFORMATION IS 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
    115943 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR