BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2970386 · Received February 20, 2013

    Report

    Report Number
    2183996-2013-00220
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 3, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. IT WAS UNKNOWN IF THE PATIENT USED ANY CONCOMITANT MEDICAL PRODUCTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT THE MENU BUTTON ON HIS INFUSION DEVICE WAS NOT FUNCTIONING. THE BUTTON DOES NOT MAKE AN AUDIBLE SOUND WHEN PRESSED. 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 REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74034 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 014 YR