BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2051380 · Received April 4, 2011

    Report

    Report Number
    2183996-2011-00798
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    January 7, 2011
    Report Date
    March 7, 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
    GA, 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 LEAKING AT THE INFUSION SITE. PT STATED HE HAS BEEN USING THE INFUSION SETS FOR A COUPLE OF MONTHS AND HE WOULD NOTICE LEAKING "QUITE OFTEN". PT REPORTED HE HAS FACED ELEVATED BLOOD GLUCOSE READINGS DUE TO THIS ISSUE. PT STATED HE HAS BEEN EXPERIENCING ELEVATED READINGS FOR 5-6 WEEKS. PT REPORTED AN EXAMPLE OF AN ELEVATED READING WAS OVER 200 MG/DL. PT'S TARGET BLOOD GLUCOSE IS 130 MG/DL. PT USES THE INSERTION ASSIST PLUS DEVICE TO INSERT THE INFUSION SETS. PT STATED HE NOTICED UPON INSERTION THAT THE INTRODUCER NEEDLE WOULD NOT PUNCTURE HIS SKIN. PT REPORTED HE WOULD THEN PUSH THE NEEDLE MANUALLY INTO THE INFUSION SITE AND THAT HE WOULD THEN NOTICE LEAKING AT THE SITE WITHIN MINUTES OF INSERTING. PT STATED UPON REMOVING THE INFUSION SET CANNULA, HE WOULD NOTICE ONE BEND IN THE CANNULA. PT REPORTED HE WOULD BOLUS TO BRING HIS BLOOD GLUCOSE LEVEL DOWN. PT HAS DISCARDED THE ALLEGED INFUSION SETS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REPLACEMENT INFUSION SETS WERE SENT; 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 62 YR INSULIN INFUSION PUMP| INSULIN