BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2081522 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00957
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 RECEIVING HIGHER BLOOD GLUCOSE READINGS WHILE USING THE INFUSION SETS. PT STATED THERE WAS A LEAK AT THE INFUSION SITE DUE TO A BENT CANNULA. PT REPORTED, HIS BLOOD GLUCOSE WENT UP TO ABOUT 400 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 100-180 MG/DL. PT STATED, HE WAS ABLE TO BRING HIS BLOOD GLUCOSE BACK DOWN WITH THE INFUSION DEVICE. PT REPORTED, HE NOTICED THE LEAK BECAUSE, HIS BLOOD GLUCOSE WAS ELEVATED SO HE CHECKED THE INFUSION SET. PT STATED, WHEN HE REMOVED THE INFUSION SET HE NOTICED THE INFUSION SET WAS BENT. PT REPORTED, THE INFUSION SET WAS IN USE FOR ABOUT 6 HOURS. PT MANUALLY INSERTS THE INFUSION SETS. PT STATED THE ISSUE OCCURRED ONCE AND HE 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 GWX123

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR INSULIN| INSULIN INFUSION PUMP