BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP MMT-715NAL

    MDR report key: 1981021 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80280
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 500MG/DL. IT WAS STATED THAT THE DOCTOR REQUESTED A REPLACEMENT OF THE INSULIN PUMP BEFORE RELEASING THE CUSTOMER. ADVISED THE DOCTOR THAT A REPLACEMENT OF THE DEVICE WOULD BE SENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP MMT-715NAL INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization