BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1951863 · Received December 28, 2010

    Report

    Report Number
    2032227-2010-83572
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC MINIMED
    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 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 DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 179MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE CHANGES THE INFUSION SET EVERY THREE DAYS. THE CUSTOMER STATED THAT SHE FELT SICK AND TREATED WITH A MANUAL INJECTION. THE CUSTOMER STATED THAT SHE WOKE UP WITH DIABETES KETOACIDOSIS. THE TIME AND DATE ON THE INSULIN PUMP WERE CORRECT. ATTEMPTED TO REVIEW THE PROGRAMMING, BUT THE CUSTOMER ALREADY HAD CHANGED THE BASAL RATES. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization