BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAH PRDGM INS PK

    MDR report key: 1842907 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-82836
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 AND DIABETES KETOACIDOSIS OF OVER 700 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL CONTINUED TO RUN HIGH, AND SHE FELT SICK. THE CUSTOMER ALSO STATED THAT THE DOCTOR DETERMINED THAT SHE WAS NOT COUNTING THE CARBOHYDRATES CORRECTLY, WHICH CAUSED THE RISE TO HER GLUCOSE LEVEL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAH PRDGM INS PK INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization