BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2072998 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01138
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE INSULIN INFUSION SET
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1486-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT HE EXPERIENCED HYPERGLYCEMIA WHILE USING THE INFUSION SETS. HE USED THIS TYPE OF INFUSION SET FOR 1.5 MONTHS. ONE INFUSION CANNULA BENT AS IT WAS INSERTED INTO HIS SKIN. THE INSERTION "FELT DIFFERENT," AND HE REMOVED THE HEADSET AND NOTICED THE CANNULA WAS BENT. ANOTHER HEADSET WAS INSERTED USING THE INSERTION DEVICE. HIS BLOOD GLUCOSE INCREASED TO 500 MG/DL THE NEXT DAY. PT DELIVERED AN INSULIN INJECTION TO LOWER BLOOD GLUCOSE, AND HE INSPECTED THE INFUSION SITE AND NOTICED INSULIN WAS LEAKING UNDERNEATH THE ADHESIVE. WHEN THE HEADSET WAS REMOVED, THE CANNULA WAS "STRAIGHT AND FINE." TARGET BLOOD GLUCOSE IS 105 MG/DL. PT ALSO EXPERIENCED INSULIN LEAKAGE WITH ANOTHER INFUSION SET, AND WHEN THE HEADSET WAS REMOVED, THE CANNULA WAS BENT. PRODUCT WAS REPLACED. NO PRODUCT WAS AVAILABLE TO RETURN FOR EVALUATION. THE PT DID NOT REQUIRE TREATMENT FOR 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 INFUSION SET NA GWX149

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INSULIN INFUSION DEVICE| INSULIN