BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1211149 · Received October 24, 2008

    Report

    Report Number
    2032227-2008-01849
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 CALLED FOR ASSISTANCE PROGRAMMING A BOLUS ON THE INSULIN PUMP. WHILE CHECKING THE HISTORY FILES, IT WAS FOUND THAT THE CUSTOMER WAS DELIVERED A BOLUS OF 23.5 UNITS OF INSULIN PRIOR TO THE PHONE CALL. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE START OF THE PHONE CALL WAS 171 MG/DL, BUT IT QUICKLY DROPPED TO 71 MG/DL. PARAMEDICS WERE CALLED AND ARRIVED ON THE SCENE TO ASSIST THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention