BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2031250 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00534
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 2, 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 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'S MOTHER REPORTED, THE PT EXPERIENCED A BENT INFUSION SET CANNULA 2 WEEKS AGO. THE PT'S TRAINER ASSISTED IN INSERTING THE HEADSET MANUALLY AND IT WAS IN PLACE FOR 3 DAYS. WHEN THE HEADSET WAS REMOVED, THE CANNULA WAS BENT AND WAS ON THE OUTSIDE OF THE PT'S BODY. THERE WAS ALSO BRUISING IN THE AREA. THE PT WAS USING SALINE IN THE INFUSION DEVICE AT THE TIME OF THE INCIDENT, THEREFORE, THERE WERE NO PHYSIOLOGICAL EFFECTS. 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 13 YR INSULIN INFUSION PUMP| INSULIN