BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1993728 · Received January 26, 2011

    Report

    Report Number
    2183996-2011-00053
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    MOTHER REPORTED THE PLASTIC PART OF THE INFUSION SET CANNULA HAS SNAPPED IN HALF WHEN PATIENT ENGAGES IN ACTIVITY. IT WAS ALSO REPORTED THE INFUSION TUBE CONNECTOR DETACHES FROM THE HEADSET CONNECTOR. THIS APPEARS TO HAPPEN AT ANY TIME AND RESULTS IN ELEVATED BLOOD GLUCOSE. ON TWO OCCASIONS, THIS OCCURRED IN THE MIDDLE OF THE NIGHT. TWO INFUSION SETS WERE RETURNED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR INSULIN INFUSION DEVICE| INSULIN