BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1210222 · Received October 22, 2008

    Report

    Report Number
    2032227-2008-01819
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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 COMPLAINED OF HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED THAT HIS LAST BLOOD GLUCOSE READING WAS 487 MG/DL. DURING THE PHONE CALL, THE CUSTOMER SOUNDED WEAK AND SLOW OF SPEECH. PARAMEDICS WERE CALLED TO ASSIST THE CUSTOMER. THE CUSTOMER WAS ADVISED TO CALL BACK TO PERFORM TROUBLESHOOTING ON THE INSULIN PUMP WHEN HIS BLOOD GLUCOSE LEVELS ARE STABLE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention