BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070246 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01103
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1490-2011
    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

    PATIENT EXPERIENCED HYPERGLYCEMIA OF 500 MG/DL DUE TO THE INFUSION SETS, AND THIS RESULTED IN A HOSPITALIZATION. PATIENT CHANGED THE INFUSION SET AT NIGHT AND WOKE AT 7 A.M. THE NEXT DAY WITH BLOOD GLUCOSE OF 300 MG/DL. HE ATE BREAKFAST AND DELIVERED A CORRECTION BOLUS. PATIENT WENT TO SCHOOL, AND HIS BLOOD GLUCOSE WAS 500 MG/DL WHEN HE ARRIVED. HE WAS DIZZY AND VOMITED. PATIENT WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS AND HAD DIFFICULTY DECREASING BLOOD GLUCOSE BELOW 350 MG/DL. PATIENT CONTINUED TO EXPERIENCE DIFFICULTIES WITH ELEVATED BLOOD GLUCOSE FOLLOWING DISCHARGE. INFUSION SETS WERE REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX167

    Patients

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