BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAP PRDGM INS V2.1 PL EN

    MDR report key: 1060260 · Received June 11, 2008

    Report

    Report Number
    2032227-2008-00976
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    April 5, 2008
    Report Date
    May 29, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST INCLUDING THE BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE INSULIN PUMP HAD A CRACK ON THE RESERVOIR TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER CALLED TO REPORT A CRACK ON THE INSULIN PUMP DUE TO THE INSULIN PUMP BEING DROPPED. THE MOTHER THEN STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER WAS VOMITING DUE TO THE HIGH BLOOD GLUCOSE LEVELS. NOTHING FURTHER WAS REPORTED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization