BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081496 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00979
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1489-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HE EXPERIENCED HYPERGLYCEMIA DUE TO BENT AND KINKED INFUSION CANNULAS. BLOOD GLUCOSE ELEVATED TO APPROX 320 MG/DL, AND NORMAL BLOOD GLUCOSE IS 120-150 MG/DL. PT BOLUSED TO CORRECT HYPERGLYCEMIA, AND IF THIS DID NOT WORK, HE WOULD SWITCH TO A DIFFERENT TYPE OF INFUSION SET. THERE WERE NO ISSUES WITH THE PREPARATION, INSERTION, OR REMOVAL OF THE INFUSION SETS. THERE WAS NO INSULIN LEAKAGE. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS, AND PT NOTICED THE ISSUES IMMEDIATELY FOLLOWING INSERTION. THIS FIRST OCCURRED IN (B)(6) 2011, AND HAPPENED MORE THAN ONCE. NO PRODUCT WAS REQUESTED FOR EVAL. PRODUCT WAS REPLACED. 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 GWX151

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR INSULIN INFUSION DEVICE| INSULIN