BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2031098 · Received March 16, 2011

    Report

    Report Number
    2032227-2011-00661
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    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 UNKNOWN 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 BLOOD GLUCOSE LEVELS, WITH A READING OF 30 MG/DL. THE CUSTOMER WAS FOUND UNCONSCIOUS BY HER HUSBAND, AND TAKEN TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE DAILY TOTALS AND RESERVOIR VOLUME BOTH WERE CORRECT. THE CUSTOMER MENTIONED THAT SHE HAD AN MRI SEVERAL MONTHS AGO. SHE REMOVED THE INSULIN PUMP FROM HER BODY, BUT LEFT IT IN THE ROOM. CONDUCTED THE DISPLACEMENT TEST, AND THE INSULIN PUMP PASSED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization