BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523LNAS PRDGM INS V2.3 SK EN LN

    MDR report key: 1870115 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82909
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 REPORTED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. AFTER THE EVENT, THE CUSTOMER'S INSULIN PUMP WAS EITHER MISPLACED, LOST OR STOLEN. NO TROUBLESHOOTING WAS PERFORMED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523LNAS PRDGM INS V2.3 SK EN LN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization