BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 883880 · Received July 20, 2007

    Report

    Report Number
    2183996-2007-01047
    Event Type
    Injury
    Date Received
    July 20, 2007
    Date of Event
    June 15, 2007
    Report Date
    July 10, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K033892
    Removal / Correction Number
    Z-1116/1146-6
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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 SUPPLEMENT REPORT. ACCU-CHECK FLEXLINK IS SAME PRODUCT AS ACCU-CHECK ULTRAFLEX WHICH IS SOLD IN THE UNITED STATES UNDER 510(K) # K033892.

    Description of Event or Problem · 1

    THE PT STATED THAT IN 2007, SHE EXPERIENCED 6 INFUSION SETS SEPARATE AT THE LUER CONNECTION. THE PT STATED THAT ON ONE OCCASION DUE TO THE SEPARATION HER BLOOD GLUCOSE WAS ELEVATED TO 350 MG/DL WHEN SHE WOKE UP IN THE MORNING. SHE LOWERED HER BLOOD GLUCOSE BY CHANGING THE INFUSION SET AND BOLUSING THROUGH HER INFUSION DEVICE. THE PT DISCARDED ALL OF THE ALLEGED INFUSION SETS. SHE WILL BE RETURNING THE UNUSED INFUSION SETS FROM THE ALLEGED BOX. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. ACCU-CHEK FLEXLINK 6L059UF

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention INSULIN| INSULIN INFUSION PUMP