BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL

    MDR report key: 1327179 · Received February 24, 2009

    Report

    Report Number
    MW5010071
    Event Type
    Injury
    Date Received
    February 24, 2009
    Date of Event
    December 1, 2008
    Report Date
    February 24, 2009
    Manufacturer
    SMITHS MEDICAL
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL HAS RECALLED MY INSULIN PUMP DUE TO A SOFTWARE DEFECT. THEY HAVE SENT ME OUT A USED AND UNSTERILIZED PUMP TO REPLACE THE DEFECTIVE ONE! STATED "THE FDA KNOWS ABOUT THIS." IS THIS TRUE? I DO NOT KNOW IF PREVIOUS USER HAD MRSA, AIDS, HEPATITIS OR WHAT. MAYBE A KID DROPPED IT IN THE COMMODE, WHO KNOWS? I FIND THIS PRACTICE UNACCEPTABLE FOR INFECTIOUS REASONS. MY PHYSICIAN AGREES. I AM GETTING RUN-AROUND FROM SMITHS MEDICAL. DO YOU FOLKS REALLY APPROVE OF PASSING OUT USED INSULIN PUMPS TO REPLACE DEFECTIVE ONES? I NEED A REPLY. MY NEXT CONTACT WILL BE THE NEWSPAPER. DOSE OR AMOUNT: EXTENDED BOLUS; FREQUENCY: AS NEEDED; ROUTE SQ. DATES OF USE: 2007 - 2009. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITHS MEDICAL DELTEC COZMO INSULIN PUMP LZG SMITHS MEDICAL 1800 A54271

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| S