BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED/MEDTRONIC

    MDR report key: 384350 · Received February 6, 2002

    Report

    Report Number
    MW4003233
    Event Type
    Malfunction
    Date Received
    February 6, 2002
    Manufacturer
    MEDTRONIC MINIMED INC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED COMPLAINANT WAS IN THE MINIMED INSULIN PUMP STUDY. COMPLAINANT STATED THAT COMPLAINANT HAD BEEN HAVING PROBLEMS FOR THAT PAST YEAR OR SO WITH THE PUMP (I.E. NOT DELIVERING THE RIGHT AMOUNT OF INSULIN AND VARIATION OF READINGS). COMPLAINANT ALSO MENTIONED CONTACTING THE CO AND THEY INFORMED COMPLAINANT THAT THEY WOULD RECEIVE A PUMP IN 2001 AND THE PUMP COMPLETELY DIED THE FIRST PART OF THE LAST MONTH. THEY TOLD COMPLAINANT THEIR 2 1/5 YEAR WARRANTY EXPIRED AND THEY WOULD NOT REPLACE IT. (DURING SEVERAL CALLS TO THE CO COMPLAINANT WAS ALSO ADVISED TO CONDUCT EXTERNAL INJECTIONS UNTIL THEY RECEIVED THE REPLACEMENT.) ACCORDING TO THE COMPLAINANT DURING ONE OF THE CONVERSATIONS WITH THE PHYSICIAN ASSISTANT IN DR'S OFFICE, MEDTRONICS REPLACED THE PUMPS FOR 3 OF 5 MEMBERS WHO WERE IN THE CASE STUDY. COMPLAINANT IS QUITE UPSET THAT THE CO WILL NOT REPLACE THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED/MEDTRONIC PUMP, INFUSION, INSULIN LZG MEDTRONIC MINIMED INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *