BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1063303 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01017
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. 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 WERE CALLED OUT AND TREATED HER LOW BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER TREATED HER HIGH BLOOD GLUCOSE BASED ON HER METER READINGS. THE CUSTOMER MENTIONED THAT THE PARAMEDICS METER AND HER OLD METER READING WAS 30 TO 40 POINTS LOWER THAN THE ULTRALINK METER. TROUBLESHOOTING WAS DECLINED. NO FURTHER INFORMATION 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 MINIMED MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention