BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS

    MDR report key: 1962747 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-80124
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 LOW GLUCOSE OF 32MG/DL. THE CUSTOMER STATED THAT HIS DOCTOR CHANGES THE BASALS AND SETTINGS ON THE INSULIN PUMP. THE CUSTOMER STATED THAT HE ATE LUNCH AND HIS GLUCOSE LEVEL WAS IN THE 200 RANGE. THE CUSTOMER ALSO STATED HAVING DIFFICULTIES HEARING THE DEVICE WHEN IT BEEPS. REVIEWED THE CUSTOMER'S ALERT HISTORY AND FOUND THAT THE DEVICE ALERTED WHEN HE WAS LOW BLOOD GLUCOSE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization