BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2080240 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00854
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1491-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 HER BLOOD GLUCOSE HAS BEEN STAYING UP LONGER THAN NORMAL AFTER BREAKFAST. PT STATED HER BLOOD GLUCOSE HAS RECENTLY BEEN UP TO 220-350 MG/DL. PT REPORTED HER BLOOD GLUCOSE IS USUALLY ANYWHERE FROM 70-350 MG/DL. PT REPORTED SHE WILL BOLUS AND IF IT DOESN'T BRING HER BLOOD GLUCOSE BACK DOWN SHE HAS BEEN TAKING AN INJECTION. PT STATED SHE HAS BEEN HAVING ISSUES SINCE SHE BEGAN USING THE INFUSION SETS A COUPLE OF MONTHS AGO BUT SHE DOES NOT KNOW HOW LONG EXACTLY. PT REPORTED HAVING ISSUES WITH INSERTION. PT STATED THE INFUSION SETS WOULDN'T GO IN FOR HER AND WOULDN'T PENETRATE HER SKIN. PT REPORTED THE INFUSION SITES DID NOT LEAK THAT SHE NOTICED. PT STATED THE INFUSION SET CANNULAS DID NOT BEND BUT SHE HASN'T BEEN PAYING MUCH ATTENTION. PT MANUALLY INSERTED THE INFUSION SITES. PT IS USING A COMPETITOR'S INFUSION DEVICE. PT REPORTED THE ISSUES HAVE OCCURRED MORE THAN ONCE. 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 GWX119

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR INSULIN| INSULIN INFUSION PUMP