BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2073005 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01156
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 28, 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
    WI, 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 INSULIN LEAKAGE AT THE INFUSION SITE WHILE USING THE INFUSION SET. HE STATED THE LEAKS OCCURRED WHEN THE HEADSET WAS ATTACHED BELOW THE BELT LINE. HE NOTICED THE LEAK WHEN HIS SHIRT BECAME WET. HE MOVED THE HEADSET ABOVE THE BELT LINE AND HAD NO FURTHER ISSUES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS DISCARDED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR INSULIN| INSULIN INFUSION PUMP