BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAP PRDGM INS PL EN US LN

    MDR report key: 1011880 · Received March 10, 2008

    Report

    Report Number
    2032227-2008-00465
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 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 UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER STATED THAT THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE FATHER THEN STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED. THE FATHER STATED THAT THEY HAD MADE SEVERAL CHANGES TO THE BASAL RATES, BUT THE LOW BLOOD GLUCOSE LEVELS CONTINUED. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY, THE CUSTOMER IS NEVER CONNECTED DURING THE MANUAL PRIME AND THE INSULIN PUMP COUNTED THE RESERVOIR VOLUME AMOUNT CORRECTLY. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization