BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID-D INFUSION SET

    MDR report key: 2243822 · Received September 6, 2011

    Report

    Report Number
    2183996-2011-02388
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, COMPANY REPRESENTATIVE REPORTED PATIENT WAS HAVING ADVERSE REACTIONS TO HER INFUSION SET. COMPANY REPRESENTATIVE STATED THE PATIENT REPORTED THE AREA WAS IRRITATED AND HURT WHERE HER INSERTION SITE WAS. COMPANY REPRESENTATIVE REPORTED THE PATIENT STATED SHE REMOVED THE INFUSION SET AND INSERTED ANOTHER ONE. ON FOLLOW UP CALL PATIENT REPORTED SHE HAS A WHOLE SIDE OF HER STOMACH THAT IS RED AND THE AREA WHERE THE CANNULA WAS INSERTED THERE IS A RED, PURULENT AREA. PATIENT STATED SHE HAS BEEN USING THE INFUSION SETS FOR A MONTH AND THE INFECTION STARTED ABOUT 3 DAYS AGO. PATIENT NO LONGER HAS THE INFUSION SET THAT CAUSED THE INFECTION. PATIENT REPORTED A NURSE CAME TO SEE HER AND GAVE HER AN ANTIBIOTIC OINTMENT TO PUT ON THE AREA. PATIENT STATED IF THE OINTMENT DID NOT CLEAR UP THE INFECTION SHE WOULD NEED TO TAKE AN ORAL ANTIBIOTIC. ON FOLLOW UP CALL ON (B)(6) 2011 PATIENT REPORTED THE INFECTION HAS CLEARED UP WITH THE USE OF THE ANTIBIOTIC OINTMENT. PATIENT STATED SHE DID NOT NEED TO TAKE AN ORAL ANTIBIOTIC BUT SHE DID NEED A PRESCRIPTION FOR THE OINTMENT AND THE OINTMENT WAS STARTED AS SOON AS THE INFECTION STARTED. PATIENT IS CURRENTLY USING A DIFFERENT TYPE OF INFUSION SET AND STATED THEY ARE WORKING MUCH BETTER FOR HER. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID-D INFUSION SET INSULIN INFUSION SET LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32023201

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention INSULIN INFUSION SET| INSULIN