BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3243354 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01364
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    September 10, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    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 ISOLATE THE AREA OF CONTACT INSIDE THE BUTTON HOUSING.

    Description of Event or Problem · 1

    AN EDUCATOR REPORTED THE MENU BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION CORRECTLY. HE STARTED THE INFUSION DEVICE AND WAS ABLE TO PROGRAM THE TIME AND DATE, AND THE BUTTON WOULD NOT FUNCTION AFTER. HE REMOVED AND INSERTED THE BATTERY, BUT THIS DID NOT RESOLVE THE ISSUE. THE INFUSION DEVICE WAS RETURNED TO THE AFFILIATE. A NEW BATTERY WAS INSERTED, AND THE BUTTON FUNCTIONED INTERMITTENTLY BY PRESSING A FINGERNAIL INTO THE MIDDLE OF THE PAD. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WILL BE SENT TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344288 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1