BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 834077 · Received March 29, 2007

    Report

    Report Number
    2183996-2007-00384
    Event Type
    Injury
    Date Received
    March 29, 2007
    Date of Event
    February 6, 2007
    Report Date
    March 6, 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. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENT REPORT. ACCU-CHEK FLEXLINK IS THE SAME PRODUCT AS ACCU-CHEK ULTRAFLEX, WHICH IS SOLD IN THE UNITED STATES UNDER 510(K) #K033892.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED DUE TO HER INFUSION TUBING BREAKING AND HER CANNULA WAS BENT. HER BLOOD GLUCOSE IN 2007, MEASURED 111 MG/DL AT 8AM, 40 MG/DL AT 10AM, 214 MG/DL AT 11:30AM, 57 MG/DL AT 2:40PM, 406 MG/DL AT 8:30PM, 340 MG/DL AT 10PM, AND 320 MG/DL AT 11PM. THE NEXT DAY, HER BLOOD GLUCOSE MEASURED 405 MG/DL AT 12:45AM, 300 MG/DL AT 4AM, AND 50 MG/DL AT 7AM. NO FURTHER INFORMATION IS AVAILABLE REGARDING ACTIONS TAKEN BY THE PATIENT. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 UNK

    Patients

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