BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 482554 · Received August 28, 2003

    Report

    Report Number
    MW1029423
    Event Type
    Injury
    Date Received
    August 28, 2003
    Date of Event
    August 28, 2003
    Report Date
    August 28, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPEATED "NO POWER" ALARMS WITH NO WARNING. ALSO, "NO POWER" ALARM IMMEDIATELY AFTER "LOW BATTERY" ALARMS -LITTLE WARNING-. REPORTER CONTACTED THEIR MINIMED PUMP EDUCATOR WHO EXPLAINED THAT THE COMPANY HAD PROBLEMS WITH THIS VERSION OF THE SOFTWARE. SHE INSTRUCTED REPORTER TO CONTACT MINIMED FOR A NEW PUMP WITH THE NEWEST SOFTWARE ON IT. THE TECHNICAL SERVICE REP COULD ONLY AUTHORIZE A REPLACEMENT "REFURBISHED" PUMP. REPORTER EXPRESSED THEIR CONCERNS OVER RECIEVING A "REFURBISHED" PRODUCT, BUT TO NO AVAIL. 7-03: THE FIRST REPLACEMENT PUMP RESULTED IN HIGH BLOOD SUGARS AFTER EVERY PRIME. REPORTER CALLED TECHNICAL SERVICES AND THEY SENT A SECOND REPLACEMENT. REPORTER AGAIN EXPRESSED THEIR CONCERNS OVER RECEIVING REFURBISHED PARTS. THE THIRD REFURBISHED PUMP ALSO RESULTED IN HIGH BLOOD SUGARS AFTER PRIMING. REPORTER ALSO RECEIVED A "NO POWER" WARNING WHILE USING THIS PUMP. REPORTER AGAIN CONTACTED TECHNICAL SERVICES. THE REP SENT THE THIRD REFURBISHED PUMP. THE REP EXPLAINED THAT IN SOME PUMPS THE PRESSURE INSIDE THE RESERVOIR CAVITY WAS NOT CORRECT. THIS RESULTED IN NO OR LIMITED INSULIN DELIVERY. REPORTER AGAIN EXPRESSED THEIR CONCERNS OVER THE RECEIPT OF A REFURBISHED MODEL. THE REP EXPLAINED THAT HE WAS NOT AUTHORIZED TO SEND A NEW PUMP BUT THAT HE WOULD HAVE HIS MANAGER CONTACT RPTR. THE MANAGER DID NOT CALL, SO REPORTER CALLED BACK AND SPOKE WITH HER. SHE FILED A REQUEST FOR A NEW PUMP WHICH WAS DENIED BY THE VICE PRESIDENT. SHE INSTRUCTED REPORTER TO CONTACT REPORTER LOCAL SALES REP WHO COULD ARGUE REPORTER POINT FROM ANOTHER AVENUE. 8-2003: RECEIVED MULTIPLE "NO POWER" AND "BOLUS STOPPED" ALARMS FROM THE THIRD REFURBISHED PUMP. REPORTER AGAIN CALLED TECHNCICAL SERVICES. THEY OFFERED TO SEND ANOTHER REFURBISHED PUMP. RPTR ASKED TO SPEAK WITH THE VICE PRESIDENT WHO IS IN CHARGE OF ISSUING NEW PUMPS. THE REP TOOK RPTR'S NAME AND PHONE NUMBER SO THAT HE COULD CALL RPTR WHEN HE CAME IN. HE HAS NEVER CONTACTED THEM. REPORTER CONTACTED THEIR DR'S OFFICE WHO HAD THEIR LOCAL SALES REP CONTACT THEM. SHE FILED A REQUEST FOR A NEW PUMP WHICH WAS ALSO DENIED. REPORTER IS CURRENTLY USING A FAULTY PUMP AND IS OFTEN LEFT STRANDED WITH NO INSULIN DELIVERY. REPORTER HAS RETURNED ALL THREE OF THE EARLIER REPLACEMENT PUMPS AND REQUESTED A LETTER OF EXPLANTATION FORM THE COMPANY AFTER THE INSPECTION IS COMPLETED. SO FAR REPORTER HAS NOT RECEIVED THIS LETTER. THIS PRODUCT IS UNRELIABLE AND UNSAFE. REPORTER BELIEVES MINIMED SHOULD BE FORCED TO REPLACE THESE DEVICES WITH NEW PRODUCTS IN PERFECT WORKING ORDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| O| R