BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAB PRDGM INS V2.1 BL EN

    MDR report key: 1222055 · Received November 3, 2008

    Report

    Report Number
    2032227-2008-01897
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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 HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 233 MG/DL. THE CUSTOMER'S NURSE DECLINED TO PERFORM TROUBLESHOOTING ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization