BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL

    MDR report key: 1973836 · Received January 20, 2011

    Report

    Report Number
    2032227-2011-00181
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CALLED REQUESTING ASSISTANCE WITH SETTING THE DATE/TIME AND UPDATING BASALS. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE AND DID NOT KNOW HOW MUCH INSULIN TO TAKE. WHILE ASSISTING THE CUSTOMER, SHE DID FEEL SICK AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS WENT TO THER HOME TO ASSIST HER UPDATING THE DATE AND TIME. THE DEVICE WAS REWIND AND A MANUAL PRIME TEST WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization