BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081520 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00990
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 13, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1486-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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'S WIFE REPORTED THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 300 MG/DL, BENT INFUSION SET CANNULAS, AND INSULIN LEAKAGE WHILE USING THE INFUSION SETS. HIS NORMAL BLOOD GLUCOSE RANGE IS 100-120 MG/DL. HE SELF TREATED BY CHANGING THE HEADSET AND EITHER BOLUSING THROUGH THE INFUSION DEVICE OR INJECTING INSULIN VIA SYRINGE TO LOWER HIS BLOOD GLUCOSE. HE WOULD BEGIN TO FEEL UNWELL AND WOULD LOOK AT THE INFUSION SITE AND FIND INSULIN LEAKAGE BENEATH THE ADHESIVE OR A BENT CANNULA THAT WAS NOT IN HIS BODY. HE INSERTS THE HEADSETS EITHER MANUALLY OR BY USING THE INSERTION DEVICE AROUND HIS WAIST AND BACK. THIS OCCURRED UP TO 3 TIMES IN ONE DAY. 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 WAS REQUESTED TO 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 GWX125

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR INSULIN| INSULIN INFUSION PUMP