BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAH PRDGM INS V2.4 PK

    MDR report key: 1812230 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82571
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 REPORTED THAT SHE WAS HOSPITALIZED DUE TO A MIGRAINE. THE CUSTOMER WAS VERY SICK AND WENT INTO A DIABETES KETOACIDOSIS. THE CUSTOMER STATED THAT THE HOSPITAL TOOK OFF THE INSULIN PUMP AND TREATED HER WITH INSULIN DRIP. THE CUSTOMER STATED THAT THE BATTERY WAS RE-INSTALLED AND THE DEVICE ALARMED. WHILE THE CUSTOMER WAS GETTING A NEW BATTERY, THE CALL GOT DISCONNECTED AND NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAH PRDGM INS V2.4 PK INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization