BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1070903 · Received June 30, 2008

    Report

    Report Number
    3004209178-2008-00461
    Event Type
    Injury
    Date Received
    June 30, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 354 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER RECEIVED A NO DELIVERY ALARM. RAN A FIXED PRIME TEST AND PASSED. THE CUSTOMER STATED THAT THE DOCTOR BELIEVES THAT CUSTOMER DID NOT HAVE ENOUGH INSULIN IN HIS BODY. NO FURTHER INFO WAS PROVIDED.

    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 MMR-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization