BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070378 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01085
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 19, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT'S MOTHER REPORTED THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 200-300 MG/DL WHILE USING THE INFUSION SETS DUE TO A BENT CANNULA THAT CAUSED INSULIN LEAKAGE. THE PATIENT NOTICED THE BENT CANNULA AND INSULIN LEAKAGE WHEN THE HEADSET FELL OFF OF HIS BODY. THE INFUSION SET HAD BEEN IN USE FOR 2 DAYS. THE ISSUE OCCURRED 3-4 TIMES. THE PATIENT BOLUSED THROUGH THE INFUSION DEVICE TO LOWER HIS BLOOD GLUCOSE. HE USED THE INSERTION DEVICE TO INSERT THE HEADSET. THE MOTHER STATED THAT THE PATIENT'S NORMAL BLOOD GLUCOSE RANGE HAS BEEN IN THE 200'S MG/DL LATELY. THE PATIENT 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 EVALUATION.

    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 14 YR INSULIN INFUSION PUMP| INSULIN