BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723PNAS PRDGM INS V2.3 SK EN PW

    MDR report key: 1873080 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82945
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING TREATMENT AT THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 572 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP ALARMED NO RESERVOIR. ADVISED CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention