BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENLET PLUS, LIFESCAN

    MDR report key: 1141923 · Received August 27, 2008

    Report

    Report Number
    MW5008131
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 27, 2008
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SCREW THREADS THAT SECURE THE TOP OF THE PENLET PLUS LANCET TO THE BOTTOM DISINTEGRATED OVER THE COURSE OF A FEW MONTHS SO THAT THE DEVICE NO LONGER WORKED, WHICH LEFT ME UNABLE TO TEST MY BLOOD SUGAR. I HAVE HAD SEVERAL OF THESE DEVICES, ALL OF WHICH DID THE SAME OVER THE COURSE OF A FEW MONTHS. I CHECK MY BLOOD SUGAR ONE OF FOUR TIMES A DAY -USUALLY TWICE A DAY-. I AM VERY, VERY CAREFUL WITH THE DEVICE, BUT THE PLASTIC APPEARS TO BE SUCH THAT IT DISINTEGRATES EASILY. ALSO, THERE APPEARS TO BE A DESIGN FLAW IN THAT ONLY A THIN LINE OF THREADS SECURES THE TOP PART TO THE BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENLET PLUS, LIFESCAN LANCET FMK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other