BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1855169 · Received September 30, 2010

    Report

    Report Number
    2183996-2010-02008
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    April 15, 2010
    Report Date
    September 15, 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
    FL, 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 BEING HOSPITALIZED WITH AN EXTREMELY ELEVATED BLOOD GLUCOSE. PT STATED HIS BLOOD GLUCOSE WAS OVER 900 MG/DL UP TO AROUND 1200 MG/DL BECAUSE THE CANNULA WAS BENT ON HIS INFUSION SET. PT REPORTED THE INFUSION SET MAY HAVE BEEN IN USE FOR TOO LONG OR INSERTED AT A WRONG ANGLE. PT STATED THE INFUSION SET WAS IN USE FOR 4 OR 5 DAYS AND THAT HE USUALLY CHANGES IT EVERY 3 OR 4 DAYS. EDUCATED PT WENT ON TO CHANGE THE INFUSION SETS. PT REPORTED HE WAS TREATED BY THE HOSPITAL WITH INSULIN. PT STATED HE DISCARDED THE INFUSION SET. 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 9H157UF

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP