BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAS PRDGM INS SK EN RC

    MDR report key: 1781311 · Received July 28, 2010

    Report

    Report Number
    2032227-2010-82017
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 10, 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 SICK AND THROWING UP. THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 734 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING IN THE INSULIN PUMP WAS OK. THE TIME WAS OFF WITH AN HOUR AND THE ALARM HISTORY REVEALED SEVERAL NO DELIVERY ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAS PRDGM INS SK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization