BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LWWS PRDGM INS V2.1 SK EN

    MDR report key: 1770201 · Received July 20, 2010

    Report

    Report Number
    2032227-2010-81917
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA. AFTER TREATMENT, THE CUSTOMER GOT BACK ON THE INSULIN PUMP, THEN EXPERIENCED HYPERGLYCEMIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LWWS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization