BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAP PRDGM INS PL EN US LN

    MDR report key: 1092105 · Received July 31, 2008

    Report

    Report Number
    2032227-2008-01323
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 20, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE CUSTOMER'S NURSE REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 470 MG/DL. TROUBLESHOOTING COULD NOT BE PERFORMED AT THE TIME OF THE PHONE CALL, BECAUSE THE NURSE DID NOT HAVE ACCESS TO AN INFUSION SET AND RESERVOIR, AND DID NOT KNOW THE CUSTOMER'S SETTINGS. THE CUSTOMER'S NURSE WAS ADVISED TO CALL BACK TO PERFORM TROUBLESHOOTING WHEN AN INFUSION SET AND RESERVOIR ARE AVAILABLE. 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