BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1133360 · Received August 22, 2008

    Report

    Report Number
    2032227-2008-01428
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 3, 2008
    Manufacturer
    MEDTRONIC MINIMED
    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. 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 REQUESTED ASSISTANCE IN TURNING OFF THE COMMUNICATION BETWEEN HER ULTRALINK AND THE INSULIN PUMP. FEW DAYS LATER, THE CUSTOMER CALLED BACK AND REPORTED BEING TREATED AT THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO STATED THAT SHE WAS NAUSEATED WHEN SHE ARRIVED AT THE HOSPITAL. THE BLOOD GLUCOSE READING WAS 198 MG/DL. CUSTOMER WAS INSTRUCTED TO TRY A DIFFERENT INFUSION SET BY HER DOCTOR, AS IT WAS SUSPECTED THAT IT COULD BE THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    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 Hospitalization