BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2030701 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00576
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1483-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT OFTEN EXPERIENCED TOO HIGH OF A BLOOD GLUCOSE LEVEL, AND WHEN SHE CHECKED THE INFUSION SET, SHE NOTICED THE INFUSION CANNULA WAS NOT INSERTED IN HER SKIN. THE INFUSION CANNULA WAS BETWEEN HER SKIN AND THE INFUSION SET ADHESIVE. PT EXPERIENCED THIS ISSUE WHEN INSERTING THE HEADSETS MANUALLY AND WITH THE INFUSION SET INSERTION DEVICE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 GWY002

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION DEVICE| INSULIN