BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2011688 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00455
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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.

    Description of Event or Problem · 1

    PT REPORTED BEING HOSPITALIZED WITH AN ELEVATED BLOOD GLUCOSE LEVEL OF 470 MG/DL. PT STATED SHE HAS HAD SEVERE PROBLEMS WITH THE INFUSION SET CANNULAS BEING KINKED. PT REPORTED SHE MANUALLY INSERTS THE INFUSION SETS. ATTEMPTS TO F/U WITH THE PT WERE UNSUCCESSFUL. NO FURTHER INFO IS AVAILABLE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN| INSULIN INFUSION PUMP