BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523RNAS PRDGM INS V2.3 SK EN RC

    MDR report key: 1921875 · Received December 6, 2010

    Report

    Report Number
    2032227-2010-83347
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    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 REPORTED THAT HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 650 MG/DL. IT WAS DETERMINED THAT THE CUSTOMER'S BELT WAS PRESSING ON THE INFUSION SET, CAUSING THE CANNULA TO BE PINCHED OFF. THE CUSTOMER WAS TREATED, THEN RELEASED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization