BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070388 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01094
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1486-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THAT SHE EXPERIENCED BENT INFUSION CANNULAS WHILE USING THE INFUSION SETS. INFUSION HEADSETS ARE INSERTED MANUALLY, AND NOTHING ABNORMAL WAS NOTED DURING THE PREPARATION OR INSERTION OF THE INFUSION SETS. THERE WAS NO INFUSION LEAKAGE. BLOOD GLUCOSE ELEVATED TO "HI" AND 494 MG/DL AS A RESULT. PT WOKE DURING THE NIGHT AND NOTICED HER BLOOD GLUCOSE WAS ELEVATED. THE HEADSET WAS INSERTED ABOUT 1.5 HOURS EARLIER. PT REMOVED THE HEADSET AND NOTICED THE CANNULA WAS BENT. PT CORRECTED HYPERGLYCEMIA BY DELIVERING INSULIN THROUGH THE INFUSION DEVICE. PT CHANGED TO A DIFFERENT TYPE OF INFUSION SET. TARGET BLOOD GLUCOSE IS 140-150 MG/DL. THIS OCCURRED A TOTAL OF 4 TIMES ON (B)(6) 2011. ONE INFUSION CANNULA WAS BENT IN 1 PLACE, AND THE OTHER 3 MINUTES WERE CRIMPED LIKE AN ACCORDION. ALLEGED INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX125

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN INFUSION DEVICE| INSULIN