BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1993441 · Received February 8, 2011

    Report

    Report Number
    2183996-2011-00141
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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

    THE PT REPORTED SHE BEGAN USING THE INFUSION SETS ON (B)(6) 2011 AND SHE DID NOT HAVE AN INSERTION DEVICE SO SHE INSERTED THE INFUSION SET HEADSET MANUALLY. SHE BEGAN TO EXPERIENCE ELEVATED BLOOD GLUCOSE OF 250-300 MG/DL ON (B)(6) 2011. HER NORMAL BLOOD GLUCOSE RANGE IS 100-150 MG/DL. ON (B)(6) 2011, SHE WENT TO THE EMERGENCY ROOM DUE TO VOMITING AND DIZZINESS. SHE WAS ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS AND WAS TREATED WITH AN INSULIN IV. WHEN THE INFUSION SET HEADSET WAS REMOVED, THE CANNULA WAS KINKED. SHE WAS RELEASED FROM THE HOSPITAL AND SHE RECONNECTED TO THE INFUSION DEVICE. SHE BEGAN TO EXPERIENCE ELEVATED BLOOD GLUCOSE (462 MG/DL) AND WHEN THE HEADSET WAS REMOVED, THE CANNULA WAS AGAIN KINKED. NO FURTHER INFORMATION IS AVAILABLE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA GWX138

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R INSULIN (DATE OF TX: (B)(6))| INSULIN INFUSION PUMP:(DT OF TX: (B)(6))