BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3963002 · Received July 29, 2014

    Report

    Report Number
    1823260-2014-05618
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 6, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K122686
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING INSULIN AT THE HEADSET. THE PATIENT NOTICED HER SHIRT WAS WET AND SHE COULD SMELL INSULIN. HER BLOOD GLUCOSE LEVEL WAS ELEVATED OVER 400 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442074 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 50466331

    Patients

    Seq Age Sex Outcome Treatment
    1