BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722WWS PRDGM INSULIN SK EN ML

    MDR report key: 1845052 · Received September 13, 2010

    Report

    Report Number
    3004209178-2010-82751
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE NURSE STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT TIME OF THE ADMISSION. ALSO, IT WAS STATED THAT THE BATTERIES IN THE DEVICE DO NOT LAST LONGER THAN TWO TO THREE DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722WWS PRDGM INSULIN SK EN ML INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1