BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LWWS PRDGM INS SK EN LN

    MDR report key: 1921826 · Received December 6, 2010

    Report

    Report Number
    2032227-2010-83346
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVELS AS HIGH AS 350 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. IT WAS ALSO REPORTED THAT THE CUSTOMER WAS GOING TO BE HOSPITALIZED FOR ONE WEEK. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LWWS PRDGM INS SK EN LN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization