BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982662 · Received February 28, 2013

    Report

    Report Number
    2183996-2013-00265
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 2, 2013
    Report Date
    March 27, 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
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED ON (B)(4) 2013. THE MENU BUTTON DOES NOT RESPOND. THERE ARE PARTICLES OF PLASTIC INSIDE THE HOUSING OF THE MENU BUTTON. THE PARTICLES TEMPORARY 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

    ON (B)(6) 2013, IT WAS REPORTED THAT THE MENU BUTTON ON THE PATIENT'S INFUSION DEVICE WOULD NOT FUNCTION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88016 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR