BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522WWS PRDGM INSULIN SK EN ML

    MDR report key: 2971282 · Received July 16, 2007

    Report

    Report Number
    3004209178-2007-04730
    Event Type
    Injury
    Date Received
    July 16, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 5, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR UNKNOWN HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE HIGH PRESSURE AND SELF TESTS. THE INSULIN PUMP WAS ALSO PROGRAMMED CORRECTLY. IT WAS ALSO STATED THAT THE INSULIN PUMP WAS EXPOSED TO AN MRT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522WWS PRDGM INSULIN SK EN ML INFUSION PUMP CGA MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization