BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1931195 · Received December 10, 2010

    Report

    Report Number
    3004209178-2010-83562
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 600 MG/DL. THE MOTHER STATED THAT THE CUSTOMER TREATED HIS GLUCOSE LEVEL WITH MANUAL INJECTIONS, AND HIS GLUCOSE LEVEL STILL DID NOT DROP. THE MOTHER STATED THAT THE CUSTOMER WAS USING THE INSULIN PUMP THERAPY AND HIS BLOOD GLUCOSE LEVEL ARE FINE. 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 MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization