BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    MDR report key: 1812303 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82590
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    THE CUSTOMER REPORTED THAT SHE IS PREGNANT AND EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE PASSED OUT, AND THE PARAMEDICS WERE CALLED. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE SHE WAS TREATED AND RELEASED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 20MG/DL BEFORE AND HER GLUCOSE LEVEL WENT UP TO 97MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING WAS CORRECT. THE UNITS OF INSULIN LEFT ON THE SCREEN MATCHED TO THE AMOUNT OF INSULIN IN THE RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention