BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2896333 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01914
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE 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 SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED INSULIN LEAKED FROM THE INFUSION SET WHEN HE PROGRAMMED A BOLUS BEFORE DINNER. HE EXPERIENCED HYPERGLYCEMIA AND NAUSEA AS A RESULT. HE CHANGED THE INFUSION SET AND HIS BLOOD GLUCOSE NORMALIZED. THE HEADSETS ARE INSERTED ON HIS ABDOMEN OR BUTTOCKS WITH AN INSERTION DEVICE. THE INFUSION SET IS CHANGED EVERY 3 DAYS. PT BELIEVES THE CANNULA AND NEEDLE WERE NOT CONNECTED CORRECTLY. THE INFUSION SET WAS REQUESTED FOR EVAL. HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK FPA ROCHE INSULIN DELIVERY SYSTEMS INC 00700006963 7490242

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP