BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3902501 · Received June 30, 2014

    Report

    Report Number
    1823260-2014-04766
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 28, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    PATIENT REPORTED HE EXPERIENCED REDNESS AND SWELLING WHILE USING THE INFUSION SET. PATIENT STATED THE REDNESS AND SWELLING BEGAN ON (B)(6) 2014 AND HE SAW THE DOCTOR ON (B)(6) 2014. PATIENT REPORTED THE DOCTOR PRESCRIBED AN ORAL ANTIBIOTIC. PATIENT STATED HE SCRUBBED THE AREA BEFORE INSERTING THE INFUSION SET. PATIENT REPORTED HE IS CURRENTLY FINE AND THE SWELLING AND REDNESS ARE NEARLY GONE. PATIENT DISCARDED THE ALLEGED INFUSION SET; NO PRODUCT TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380302 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR Required Intervention SPIRIT INSULIN PUMP| HUMALOG