BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAS PRDGM INS SK EN US LN

    MDR report key: 1060254 · Received June 11, 2008

    Report

    Report Number
    2032227-2008-00967
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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

    THE CUSTOMER CALLED TO GET A REPLACEMENT BATTERY CAP FOR HER INSULIN PUMP,. THE CUSTOMER STATED THAT SHE WANTED TO HAVE IT SHIPPED TO THE HOSPITAL WHERE SHE WAS STAYING. THE REASON FOR THE CUSTOMER BEING IN THE HOSPITAL WAS UNKNOWN. FOLLOW-UP CALLS WERE MADE TO FIND OUT WHY THE CUSTOMER WAS IN THE HOSPITAL, BUT THE CUSTOMER COULD NOT BE REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization