BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1842820 · Received September 15, 2010

    Report

    Report Number
    2183996-2010-01943
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    May 31, 2010
    Report Date
    August 31, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6)2010, THE PATIENT REPORTED THAT HE HAS EXPERIENCED SKIN INFECTIONS AT HIS INFUSION SITE ON 3 OCCASIONS OVER THE PAST 2-3 MONTHS. HE STATED HE WENT TO THE DOCTOR AND WAS PRESCRIBED AN ANTIBIOTIC TO RESOLVE THE INFECTION. NO BLOOD GLUCOSE ISSUES WERE REPORTED. THE INFUSION SETS ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention INSULIN INFUSION PUMP| INSULIN