BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    MDR report key: 1931036 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-83531
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE ALL DAY. THE PARAMEDICS WERE CALLED AND LEFT THIRTY MINUTES LATER AFTER DRINKING JUICE TO TREAT HIS LOW GLUCOSE. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE AFTER CHANGING THE INFUSION SET. IT WAS STATED THAT THE CUSTOMER WAS DISCONNECTED SOMETIMES AND CONNECTED AT OTHERS. THE TIME ON THE DEVICE WAS CORRECT. THE WIFE STATED THAT THE CUSTOMER WAS DISCONNECTED FOR FOUR HOURS AND HIS GLUCOSE LEVEL STILL WAS LOW. ADVISED WIFE TO DISCONNECT THE INSULIN PUMP UNTIL THEY CAN CONTACT THE ENDOCRINOLOGIST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAS PRDGM INSULIN SMOKE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization