BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 834054 · Received March 29, 2007

    Report

    Report Number
    2183996-2007-00382
    Event Type
    Injury
    Date Received
    March 29, 2007
    Date of Event
    February 1, 2007
    Report Date
    March 1, 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 REPORTED THAT IN 2007, HIS BLOOD GLUCOSE MEASURED 108 MG/DL AT 6PM AND AT 10:30PM HIS BLOOD GLUCOSE MEASURED 111 MG/DL. THE NEXT DAY, AT 3:15AM, HIS BLOOD GLUCOSE MEASURED 349 MG/DL AND HE DISCOVERED THAT HIS INFUSION TUBING HAD SEPARATED FROM THE LUER. HE STATED THAT HE HAS HAD THIS ISSUE FOR 2-3 MONTHS. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION REGARDING ACTIONS TAKEN BY THE PATIENT ARE 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 5E209UF

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention INSULIN| INSULIN INFUSION PUMP