BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2190606 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02088
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED EXPERIENCING INSULIN LEAKING AT THE INFUSION SITE. SHE NOTICED THE LEAK BY THE SMALL AND HER PANTS WERE WET. THIS OCCURRED ON THREE DIFFERENT OCCASIONS AND THE SITE WAS PLACED ON THE BACK OF HER HIP. SHE IS UNSURE IF THE INFUSION SET IS LEAKING OR IF INSULIN IS LEAKING FROM HER BODY. THE INFUSION SITE IS ALWAYS INSERTED BY HER DOCTOR AND THERE IS NO SCAR TISSUE OR BRUISING. THERE IS A LUMP AFTER THE INFUSION SITE IS REMOVED WHERE INSULIN IS NOT ABSORBED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED INFUSION SET WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVAL.

    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 INSULIN INFUSION PUMP| INSULIN