BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3932860 · Received July 14, 2014

    Report

    Report Number
    1823260-2014-05224
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 26, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER STATED THE INFUSION TUBE BECAME DISCONNECTED FROM THE INFUSION DEVICE WHEN SHE WAS SLEEPING, AND SHE FELT WETNESS AND WOKE UP. THE TUBE HAD BEEN IN USE FOR 3 DAYS, AND SHE RECONNECTED THE TUBE AND CONTINUED TO USE THE PRODUCT. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410885 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1