BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1853355 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82975
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 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 BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 254MG/DL. THE CUSTOMER STATED THAT THE PARAMEDICS CAME TO HOME TO TREAT HIS LOW GLUCOSE LEVEL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND THE SETTINGS ON THE INSULIN PUMP WERE CORRECT. REVIEWED THE BOLUS HISTORY AND IT APPEARS THAT THE CUSTOMER DOUBLE BOLUSED FOR LUNCH. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAB PRDGM INS V2.2 BL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization