BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 2893436 · Received July 10, 2008

    Report

    Report Number
    3004209178-2008-10000
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REPORTED THAT THE PARAMEDICS TREATED HER LOW BLOOD GLUCOSE TWICE. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 86 MG/DL. THE CUSTOMER STATED THAT THE FIRST TIME SHE LOST CONSCIOUSNESS AND THE CUSTOMER WAS TREATED AT THE SCENE. THE CUSTOMER STATED THAT THE SECOND TIME OCCURRED WHEN HER BLOOD GLUCOSE WAS NORMAL AND THEN SHE WENT TO SLEEP. THE CUSTOMER STATED THAT SHE WOKE UP WHILE BEING TREATED BY THE PARAMEDICS. THE CUSTOMER STATED THAT THE INSULIN PUMP APPEARED TO FUNCTION AT THE TIME SHE CALLED. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention