BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2062608 · Received April 8, 2011

    Report

    Report Number
    2183996-2011-00922
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT'S MOTHER REPORTED THE PATIENT WAS HOSPITALIZED WITH ELEVATED BLOOD GLUCOSE OF 400-500 MG/DL. THE PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 80-146 MG/DL. THE PATIENT'S BLOOD GLUCOSE BEGAN TO INCREASE THIS MORNING. SHE CHANGED THE INFUSION SET 3-4 TIMES AND EACH TIME THE CANNULA WAS BENT. THE MOTHER STATED THE PATIENT RECEIVED INSULIN WHILE HOSPITALIZED. THE PATIENT WAS SENT REPLACEMENT INFUSION SETS. UPON FOLLOW UP ON (B)(6) 2011, THE PATIENT STATED SHE BEGAN USE OF THE REPLACEMENT INFUSION SETS AND HER BLOOD GLUCOSE DECREASED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R INSULIN INFUSION PUMP| INSULIN