BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1760444 · Received July 13, 2010

    Report

    Report Number
    3004209178-2010-81949
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. THE CUSTOMER'S SON STATED THAT HE WAS NOT SURE IF THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 156MG/DL. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND PASSED. THE CUSTOMER ALSO STATED THAT THE STATUS SCREEN DID NOT MATCH TO THE AMOUNT OF INSULIN LEFT IN THE RESERVOIR. 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 MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization