BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAH PRDGM V2.4 PK EN RC

    MDR report key: 1781317 · Received July 28, 2010

    Report

    Report Number
    2032227-2010-82039
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 11, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS ADMITTED INTO THE INTENSIVE CARE UNIT FOR DIABETES KETOACIDOSIS AND URINARY INFECTION. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 222MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, BASALS, DAILY TOTALS, ALARM AND BOLUS HISTORY ALL APPEARED TO BE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAH PRDGM V2.4 PK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization