BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4090113 · Received September 15, 2014

    Report

    Report Number
    1823260-2014-07012
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 4, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    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 REPORT TO THE FDA. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE HEADSET. THE INFUSION SET WAS DISCARDED; THEREFORE, NO PRODUCT COULD BE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570037 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5060061

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG U100