BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL

    MDR report key: 1973898 · Received January 20, 2011

    Report

    Report Number
    2032227-2011-00191
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 9, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE WENT IN FOR A HEART PROCEDURE AND THE DOCTOR NOTICED THAT HER GLUCOSE LEVEL WAS ELEVATING. THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP AND TREATED WITH MANUAL INJECTIONS. THE CUSTOMER ALSO STATED THAT HER GLUCOSE LEVEL WAS UP AND DOWN. ADVISED THE CUSTOMER THAT A REPLACEMENT OF THE INSULIN PUMP WOULD BE SENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization