BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAS PRDGM INSULIN SMOKE

    MDR report key: 1864745 · Received October 5, 2010

    Report

    Report Number
    3004209178-2010-83039
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS, WHICH MAY HAVE LED TO MULTIPLE ORGAN FAILURE, AND RESULTED IN BLOOD CLOTS AND MULTIPLE STROKES. TROUBLESHOOTING WAS PERFORMED. THE NURSE FILLED A RESERVOIR AND RECEIVED A LOW BATTERY ALARM. THE NURSE STATED THAT INSIDE OF THE INSULIN PUMP, SHE SMELLED INSULIN. THE NURSE REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAS PRDGM INSULIN SMOKE INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization