BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2070361 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01099
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 23, 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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Description of Event or Problem · 1

    PT REPORTED THE UP BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION PROPERLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND RETURNED FOR EVAL. THE INFUSION DEVICE WAS THOROUGHLY EVALUATED, AND THE UP BUTTON DOES NOT ALWAYS RESPOND. THE COATING BELOW THE TOP LAYER OF THE FRONT FOIL WAS WORN OFF. CONTAMINATION WITH THE RESIDUES OF THE COATING BETWEEN THE DOME CONTACT AND THE PRINTED CIRCUIT CAUSED AN INTERRUPTION, AND THIS LED TO THE NON-FUNCTIONING UP BUTTON.

    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