BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 2973741 · Received October 12, 2007

    Report

    Report Number
    3004209178-2007-04741
    Event Type
    Injury
    Date Received
    October 12, 2007
    Date of Event
    September 24, 2007
    Report Date
    September 25, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 STATED, HE WAS TREATED BY THE PARAMEDICS FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING DURING THE CALL WAS 269 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND THE PROGRAMMING WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP CGA MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention