BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    MDR report key: 1760443 · Received July 13, 2010

    Report

    Report Number
    3004209178-2010-81945
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 514MG/DL. THE CUSTOMER STATED THAT SHE HAD CHEST PAINS AND HAD OTHER HEALTH ISSUES THAT COMPOUND HER DIABETES. THE CUSTOMER WAS TREATED WITH IV DRIP AND RELEASED TWO DAYS LATER. THE CUSTOMER BELIEVED THAT THE INSULIN PUMP DID NOT CAUSE HER HIGH BLOOD GLUCOSE. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization