BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2080275 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00850
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED A BENT INFUSION SET CANNULA WITH ONE OF THE INFUSION SETS CAUSING ELEVATED BLOOD GLUCOSE. PT STATED HIS BLOOD GLUCOSE WENT OVER 400 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS IN THE 150'S MG/DL. PT REPORTED HE WAS ABLE TO TREAT HIMSELF. PT STATED HE DID NOT NOTICE ANY LEAKS WITH THE BENT INFUSION SET CANNULA. PT REPORTED THE INFUSION SET WAS IN FOR A DAY WHEN HIS BLOOD GLUCOSE LEVELS WENT UP AND THEN HE CHANGED THE INFUSION SET AND HIS BLOOD GLUCOSE CAME BACK DOWN. PT HAS DISCARDED THE ALLEGED INFUSION SET. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

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

    Patients

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