BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723RNAS PRDGM INS V2.3 SK EN RC

    MDR report key: 1910215 · Received November 22, 2010

    Report

    Report Number
    2032227-2010-83234
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER HAD JUST HAD SURGERY A FEW DAYS PRIOR, AND HER DOCTOR FELT THAT IT MAY HAVE CONTRIBUTED TO THE EVENT. THE CUSTOMER DECLINED TO DO ANY TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723RNAS PRDGM INS V2.3 SK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization