BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAL PRDGM INSULIN CLEAR EN

    MDR report key: 1841094 · Received September 16, 2010

    Report

    Report Number
    3004209178-2010-82805
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE HUSBAND STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF HER HOSPITALIZATION. IT WAS ALSO STATED THAT THE CUSTOMER TOOK A MANUAL INJECTION BEFORE BREAKFAST AND SHE DID NOT EAT ANY BREAKFAST, WHICH IT MAY HAVE CAUSE TO DROP HER BLOOD GLUCOSE. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization