BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 2103822 · Received May 18, 2011

    Report

    Report Number
    2183996-2011-01411
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED EXPERIENCING PAIN WHILE USING THE INFUSION SETS. PT STATED IT CAUSED SO MUCH PAIN THAT HE WENT TO THE EMERGENCY ROOM. PT REPORTED HE COULD FEEL THE NEEDLE IN THIS BODY WITH EVERY MOVEMENT. PT STATED HE FELT ILL, HAD BACK PAIN, ARM PAIN AND WAS URINATING BLOOD. PT REPORTED HE WAS ADMITTED TO THE HOSP. TREATMENT REC'D WAS NOT PROVIDED. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R INSULIN INFUSION SET| INSULIN