BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1202940 · Received October 15, 2008

    Report

    Report Number
    2032227-2008-01790
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 5, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE HAD TO BE REVIVED BY PARAMEDICS, DUE TO HYPOGLYCEMIA. THE CUSTOMER DECLINED TO BE TAKEN TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE DISPLACEMENT TEST PASSED. THE CUSTOMER STATED THAT SHE MAY HAVE A STOMACH VIRUS AND HAS BEEN UNDER CONSIDERABLE STRESS, POTENTIALLY CONTRIBUTING TO HER LOW BLOOD GLUCOSE LEVELS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAL PRDGM INS CL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention