BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAB PRDGM INS BL EN US LN

    MDR report key: 1201860 · Received October 15, 2008

    Report

    Report Number
    2032227-2008-01792
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 5, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSE 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 STATED THAT SHE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED AND READING THE RESERVOIR VOLUME CORRECTLY. THE CUSTOMER STATED THAT SHE LAST CHANGED HER INFUSION SET THE DAY PRIOR TO THE EVENT, BUT SHE WAS NOT CONNECTED TO THE INSULIN PUMP DURING INSERTION. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization