BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 3200921 · Received July 2, 2013

    Report

    Report Number
    2183996-2013-01201
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 24, 2013
    Report Date
    September 9, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED RETURNED TRANSFER SET WAS VISUALLY INSPECTED. UNDER THE MICROSCOPE, IT WAS CLEAR TO SEE THAT THE LUER WAS BROKEN BY EXCESSIVE FORCE.

    Additional Manufacturer Narrative · 1

    THE 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

    ON (B)(4) 2013, IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL HAD RANGED FROM 70-556 MG/DL. THE PATIENT CHECKED THE INFUSION SET AND FOUND A CRACK AT THE LUER. SHE CHANGED THE INFUSION SET AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303262 ACCU-CHEK FLEXLINK SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC 00700006965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR APIDRA