BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1060340 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-00411
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 STATED HE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED THAT HE TREATED HIS BLOOD GLUCOSE LEVEL BASED ON A READING OF 400 MG/DL HE RECEIVED FROM HIS GLUCOSE SENSOR, BUT HIS BLOOD GLUCOSE LEVEL WAS ACTUALLY 41 MG/DL ACCORDING TO HIS BLOOD GLUCOSE METER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization