BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 2971291 · Received April 9, 2008

    Report

    Report Number
    3004209178-2008-09728
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS TAKEN TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE READING OF 470 MG/DL. TROUBLESHOOTING REVEALED THAT THE CUSTOMER DID NOT HAVE ANY BASAL RATES PROGRAMMED IN THE INSULIN PUMP. THE CUSTOMER STATED THAT THIS WAS A NEW INSULIN PUMP AND SHE JUST TRANSFERRED THE SETTINGS FROM ONE INSULIN PUMP TO ANOTHER. ASSISTED THE CUSTOMER IN SETTING THE CORRECT BASAL RATES. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization