BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3880121 · Received June 18, 2014

    Report

    Report Number
    1823260-2014-04430
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 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
    CO, 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

    CALLER REPORTED SHE HAD A LEAK AT HER SITE 3 DAYS AGO. CALLER STATED SHE DETECTED THE LEAK WHEN SHE WAS GOING TO CHANGE HER SITE AND NOTICED THAT THE SELF-ADHESIVE WAS WET. CALLER DISCARDED THE ALLEGED INFUSION SET. CALLER REPORTED SHE DID NOT NOTICE IF THE CANNULA WAS KINKED. NO ADVERSE EVENT REPORTED. NO PRODUCT RETURN WAS REQUESTED, INFUSION SET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357633 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1