BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2073010 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01171
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT REPORTED EXPERIENCING INCREASED BLOOD GLUCOSE VALUES UP TO 500 MG/DL. PT STATED WHEN THE INFUSION SET NEEDLE WAS CHECKED, IT WAS BENT. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX017

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP