BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2002112 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00133
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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, PT REPORTED DIFFICULTY INSERTING HER INFUSION SETS AND THAT THE INFUSION SETS HAVE BEEN LEAKING. SHE USED A WHOLE BOX OVER THE COURSE OF THE WEEKEND BECAUSE SHE COULD NOT INSERT THE HEADSETS CORRECTLY. PT HAS RECEIVED E4 OCCLUSION ERRORS IN THE PAST, BUT IT WAS NOT HAPPENING AT TIME OF REPORT. BLOOD GLUCOSE ELEVATED TO THE 500 MG/DL RANGE. SHE USED INSULIN INJECTIONS TO LOWER BLOOD GLUCOSE TO THE 300 MG/DL RANGE. NORMAL BLOOD GLUCOSE IS 200-300 MG/DL, AND PT IS STILL TRYING TO GET HER BLOOD GLUCOSE REGULATED. INFUSION SITES BLEED WHEN THE HEADSET IS REMOVED. PT WAS SENT REPLACEMENT INFUSION SETS AND AN INSERTION DEVICE. NO PRODUCT WAS REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR INSULIN INFUSION DEVICE| INSULIN