BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2070233 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01070
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 21, 2011
    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
    TN, 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, PT REPORTED THERE WAS A RED SPOT AND IRRITATION THE SIZE OF A "SMALL PANCAKE" AT HER INFUSION SITE. THE INFUSION NEEDLE HAD BEEN IN USE FOR 3 DAYS, AND PT REMOVED IT WHEN THE AREA STARTED TO FEEL SORE. PT WAS ADVISED ON MANUFACTURER RECOMMENDATIONS. PT REPORTED THE INFUSION NEEDLE "PINCHES" HER BODY WHEN SHE SITS. PT WAS ADVISED ON INFUSION SITE LOCATIONS AND WAS ENCOURAGED TO SPEAK WITH HER PHYSICIAN. NO PRODUCT WAS REQUESTED FOR EVALUATION. F/U WAS COMPLETED WITH PT ON (B)(6) 2011. PT REPORTED THAT SHE WAS DIAGNOSED WITH AN INFECTION AT HER INFUSION SITE AND SHE REC'D AN ANTIBIOTIC. THE SURROUNDING AREA WAS RED AND FELT LIKE HOT WATER WAS RUNNING ON IT. INFUSION NEEDLE IN USE AT THE TIME OF F/U WAS "FINE," AND THERE WAS NO FURTHER PAIN, IRRITATION, REDNESS, OR SORENESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention INSULIN INFUSION DEVICE| INSULIN