BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1890044 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02193
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT'S MOTHER REPORTED THE PATIENT GOT A RASH DUE TO THE INFUSION SET. MOTHER STATED THE DOCTOR GAVE THE PATIENT A CREAM FOR THE RASH AND THEN THE RASH WENT AWAY AFTER 4 DAYS. MOTHER REPORTED THE RASH WAS CAUSED BY THE NEEDLE AND NOT THE ADHESIVE. MOTHER STATED THEY WOULD LIKE TO TRY A DIFFERENT TYPE OF INFUSION SET ALONG WITH THE INSERTION ASSIST DEVICE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 0265337

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention INSULIN| INSULIN INFUSION PUMP