BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1964094 · Received January 11, 2011

    Report

    Report Number
    2183996-2010-02758
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 27, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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) 2010, PT REPORTED SHE KEPT WAKING UP ON THE NIGHT OF (B)(6) 2010 AND HER INFUSION SITE FELT 'FUNNY'. PT STATED WHEN SHE WOKE UP ON (B)(6) 2010, HER INFUSION SITE WAS REALLY BOTHERING HER. PT REPORTED THE SITE WAS REALLY HURTING AND RED SO SHE PULLED IT OUT AND IT WAS HOT AND SWOLLEN. PT STATED THERE WAS NO DRAINAGE FROM THE INFUSION SITE AT THIS TIME. PT REPORTED "IT FELT LIKE THERE WERE WALNUTS UNDER MY SKIN." VERIFIED THAT THERE WERE LITTLE HARD BUMPS UNDER WHERE THE SITE WAS LOCATED. PT STATED SHE CLEANED THE INFECTED SITE WITH OINTMENT AND PUT A NEW INFUSION SET IN ON THE OTHER SIDE OF HER STOMACH. PT REPORTED SHE STARTED FEELING NAUSEOUS ON (B)(6) 2010 AND FELT REALLY SICK. PT STATED SHE WOKE UP ON (B)(6) 2010 AND HER INFUSION SITE ON THE OTHER SIDE WAS LOOKING THE SAME WAY. PT REPORTED IT WAS REALLY IRRITATED SO SHE WENT TO THE DOCTOR AND THEY LANCED BOTH OF THEM. PT STATED THEY CULTURED IT AND SHE IS BEING TREATED WITH ANTIBIOTICS FOR (B)(6). PT REPORTED HER BLOOD GLUCOSE WAS 524 MG/DL DUE TO THE INFECTION. PT'S TARGET BLOOD GLUCOSE RANGE IS 90-120 MG/DL. PT STATED HER DOCTOR TOLD HER TO STAY OFF OF THE INFUSION DEVICE UNTIL THESE HEAL AND PLACED HER ON INJECTION THERAPY. PT REPORTED "MY BLOOD SUGAR HAS NOT BEEN UNDER GREAT CONTROL, SO I AM SURE THIS MADE THE INFECTION WORSE." PT STATED THE INFUSION SITES ARE STILL "DRAINING LIKE CRAZY." PT REPORTED SHE HAS BANDAGES COVERING THEM UP AND SHE HAS TO KEEP THEM ON OR THEY WILL DRAIN EVERYWHERE. PT STATED SHE PLANS TO CONTACT THE DOCTOR TODAY. PT HAS DISCARDED THE ALLEGED PRODUCTS. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 0C117UF

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention INSULIN| INSULIN INFUSION SET