BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1871247 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-83072
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HIGH BLOOD GLUCOSE OF 452 MG/DL. THE CUSTOMER STATED THAT SHE WAS FEELING NAUSEOUS AND HAD SLIGHT KETONES PRIOR TO HER ADMISSION. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization