BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2980882 · Received February 27, 2013

    Report

    Report Number
    2183996-2013-00247
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 3, 2013
    Report Date
    March 25, 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

    THE PRODUCT WAS RECEIVED FOR EVALUATION ON (B)(4) 2013. 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.

    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 THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THE MENU BUTTON ON INFUSION DEVICE STARTED TO WORK INTERMITTENTLY ON (B)(6) 2013 AND NOW DOES NOT FUNCTION AT ALL. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT 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
    84825 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR INSULIN