BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAH PRDGM INS BL EN ML

    MDR report key: 1873060 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82940
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 27, 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 UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS ABOVE 400 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER EXPERIENCED NO DELIVERY ALARMS. THE CUSTOMER CHANGED THE INFUSION SET, BUT LATER BEGAN FEELING ILL AND VOMITING. IT WAS STATED THAT THE CUSTOMER'S DOCTOR WANTED THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAH PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization