BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARADIGM

    MDR report key: 924469 · Received October 3, 2007

    Report

    Report Number
    MW5003977
    Event Type
    Other
    Date Received
    October 3, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 3, 2007
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS TO SUBMIT A COMPLAINT OF CUSTOMER SUPPORT AND SERVICE FOR MEDTRONIC MINIMED. I HAVE BEEN INVOLVED WITH THE VOLUNTARY RECALL OF THE PARADIGM QUICK SET INFUSION SET IN 2004. THE ISSUES WERE RESOLVED WITH MAJOR CUSTOMER -PATIENT- STRESS. I AM CURRENTLY IN THE PROCESS OF OBTAINING A NEW INSULIN PUMP, AND HAVE BEEN FEELING ALMOST RAILROADED BY THE MEDTRONIC CORP FOR THE REASON I DID NOT FEEL THAT I HAD ALL THE INFO I NEEDED, YET THEY WERE INSISTENT THAT I AGREE TO AND PURCHASE THE PUMP AS MY INSURANCE HAD ALREADY GIVEN A PRE-APPROVAL. THE ADDED STRESS FOR SOMEONE WITH DIABETES, AND THE AVAILABILITY OF SERVICE FROM THE INSULIN PUMP MFR LEAVES ME WITH THE BELIEF THAT MEDTRONIC MINI MED IS AT CAUSE FOR - QUESTIONABLE INSURANCE CLAIMS PRACTICES AND SALES AND - PLACING THEIR PATIENTS IN JEOPARDY. I AM NOT SURE IF THIS IS THE FORUM FOR SUCH A COMPLAINT, BUT THE REQUIRED POOR SERVICE HAS HAPPENED MORE THAN ONCE AND I WANTED TO LOG AN OFFICIAL COMPLAINT IN THE EVENT THAT THIS IS WITHIN THE FDA JURISDICTION. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN PUMP LZG MEDTRONIC MINIMED PARADIGM 512
    2 PARADIGM INSULIN INSULIN PUMP LZG MEDTRONIC MINIMED PARADIGM 522

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR