BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081511 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00967
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED EXPERIENCING A LEAKY INFUSION SET. NO FURTHER INFO WAS PROVIDED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. FURTHER ATTEMPTS TO REACH THE PT FOR F/U WERE UNSUCCESSFUL. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR INSULIN INFUSION PUMP| INSULIN