BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAL PRDGM INS CL EN RC

    MDR report key: 1780959 · Received July 27, 2010

    Report

    Report Number
    2032227-2010-82022
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 CALLED TO REPORT THAT SHE WAS EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER WAS ADVISED TO GO TO THE EMERGENCY ROOM OR CALL HER DOCTOR IF HER BLOOD GLUCOSE LEVELS REMAINED HIGH. CALLED THE CUSTOMER BACK, AND FOUND THAT SHE CALLED HER DOCTOR AND HE ADVISED HER TO TREAT WITH MANUAL INJECTIONS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAL PRDGM INS CL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention