BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3943335 · Received July 18, 2014

    Report

    Report Number
    1823260-2014-05334
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT AVAILABLE TO BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING INSULIN AT THE HEADSET. THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 250 MG/DL. THE PATIENT FOUND HER SHIRT TO BE WET WITH INSULIN AND THAT IS WHEN SHE DISCOVERED THE LEAK. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS DISCARDED; THEREFORE, NO PRODUCT IS AVAILABLE FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423166 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1