BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2013037 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00435
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED, THE INFUSION SET LEAKS INSULIN BETWEEN THE HEADSET ADHESIVE AND THE CANNULA. THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 380 MG/DL AS A RESULT. THE PT CHANGED THE INFUSION SET AND BOLUSED THROUGH THE INFUSION DEVICE TO LOWER BLOOD GLUCOSE. NO FURTHER INFO IS AVAILABLE. 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 LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA GWX164

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR INSULIN| INSULIN INFUSION PUMP