BEUDAMED
    FDA Adverse Event Other Summary report: N

    APIDRA SOLO STAR

    MDR report key: 2023597 · Received March 17, 2011

    Report

    Report Number
    MW5019835
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    March 17, 2009
    Report Date
    March 17, 2011
    Manufacturer
    SANOFI AVENTIS
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS UTILIZED INSULIN PEN FOR 2 YEARS AND HAS ALWAYS HAD PROBLEMS WITH DELIVERY. HE STATES THAT THE DEVICE DOES NOT HAVE ENOUGH PRESSURE, SO IT MUST BE HELD FOR 20 SECONDS OR MORE FOR ENTIRE AMOUNT OF INSULIN TO BE ADMINISTERED. HE ALSO STATED THAT BLOOD SEEPS INTO PEN RENDERING THE DEVICE UNUSABLE AND WASTING HIS MONEY. HE HAS CONTACTED THE MFR WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APIDRA SOLO STAR INSULIN PEN FMF SANOFI AVENTIS 0FOO1A

    Patients

    Seq Age Sex Outcome Treatment
    1