BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3122760 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00898
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 26, 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
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE DISPLAY IS BROKEN DUE TO A MECHANICAL IMPACT. THE BROKEN DISPLAY CANNOT LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS.

    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

    MOTHER REPORTED THERE ARE SMALL BLACK SPOTS ON THE INFUSION DEVICE DISPLAY, AND THESE SPOTS INTERFERE WITH PATIENT'S ABILITY TO VIEW THE INSULIN DELIVERY AMOUNTS. 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
    224172 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1