BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1882611 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-83175
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    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 REPORTED THAT SHE WAS EXPERIENCING DIABETES KETOACIDOSIS AND SHE WENT OFF OF THE INSULIN PUMP AROUND THE MIDDLE OF AUGUST. THE CUSTOMER RESUMED THE INSULIN PUMP THERAPY AT THE END OF SEPTEMBER. DURING THE CALL, THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE CUSTOMER STATED THAT SHE WENT TO THE HOSPITAL ON THREE DIFFERENT OCCASIONS SINCE JUNE. THE BLOOD GLUCOSE READING WAS OVER 600MG/DL. THE CUSTOMER STATED THAT SHE TREATED HER HIGH GLUCOSE WITH A BOLUS, BUT IT WAS NOT DECREASING. NO FURTHER INFO WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization