BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 3805809 · Received May 2, 2014

    Report

    Report Number
    MW5036020
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC INSULIN PUMP RESERVOIR AND HOSE DEVELOPED AIR BUBBLES DURING USE. ABNORMALLY HIGH BLOOD SUGAR. COMPANY REPRESENTATIVE REPORTS NO PROBLEMS WITH PRODUCT. EXHIBIT B, WHICH IS THE EXACT PROTOCOL I USE EVERY TIME I CHANGE A SET IS MEDTRONIC'S ADMISSION THEIR PRODUCT IS THE PROBLEM. THIS WAS IN RESPONSE TO MY LAST COMPLAINT. MEDTRONIC'S NURSE/TRAINER HAD SEEN ME IN THE DOCTOR'S OFFICE AND CHECKED OUT MY METHODOLOGY. NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265443 MEDTRONIC INSULIN PUMP LZG MEDTRONIC 523LNAL
    265444 MEDTRONIC RESERVOIR LZG MEDTRONIC MMT 326A HGOOURO
    265445 MEDTRONIC SURE T PARADIGM FPA MEDTRONIC MMT 866 SEVERAL LOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other LINSENOPRIL| COREG| INSULIN PUMP| TYLENOL| HUMALOG