BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712WWB PRDGM INSULIN BL EN PR

    MDR report key: 1210272 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-00873
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. IT WAS REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE READING OF 350 MG/DL, FOLLOWED BY VOMITING AND BLOOD GLUCOSE LEVELS OVER 400 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712WWB PRDGM INSULIN BL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization