BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAS PRDGM INS SK EN RC

    MDR report key: 1180053 · Received September 26, 2008

    Report

    Report Number
    2032227-2008-01670
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 11 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE BOLUS HISTORY REVEALED A BOLUS OF 5.2 UNITS AND THE BASAL RATES, TIME/DATE, DAILY TOTALS, AND PRIME HISTORY APPEARS TO BE CORRECT. RAN A SELF TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization