BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2002905 · Received February 8, 2011

    Report

    Report Number
    2183996-2011-00165
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    August 30, 2010
    Report Date
    January 31, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION DEVICE WAS EVALUATED. THE DOWN BUTTON DOES NOT RESPOND. ON THE BORDER OF THE BOTTOM COVER ARE BITE MARKS, AND THE BITE MARKS CAUSED A SEPARATION OF THE KEY PAD FOIL. THE DOME CONTACT OF THE DOWN BUTTON IS CONTAMINATED, AND THIS CAUSED A NON FUNCTIONING DOWN BUTTON. NO E8 ELECTRONIC ERRORS WERE FOUND IN THE INFUSION DEVICE HISTORY. THE DELIVERY ACCURACY MET PRODUCT SPECIFICATIONS. THE DISPLAY WINDOW WAS DAMAGED. THE PROBLEM MENTIONED BY THE PT WAS RELATED TO MISHANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION DEVICE HAD ELECTRONIC PROBLEMS. NO FURTHER INFO WAS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET