BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3941141 · Received July 17, 2014

    Report

    Report Number
    1823260-2014-05299
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SHE NOTICED LEAKING AT THE SITE; WAS NOT SURE IF IT WAS A LEAK AT THE HEADSET OR POOR ABSORPTION. PATIENT STATED SHE CHANGED THE INFUSION SET AND THE LEAK DID NOT PERSIST. PATIENT DISCARDED THE INFUSION SET. NO ADVERSE EVENT REPORTED. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419402 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN - BRAND NOT KNOWN