BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2033964 · Received March 18, 2011

    Report

    Report Number
    2032227-2011-00711
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 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 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 A LOW BLOOD GLUCOSE LEVEL OF 20 MG/DL. THE CUSTOMER STATED THAT SHE ADJUSTED THE BOLUS WIZARD SUGGESTION, AND TOOK A 13 UNIT BOLUS. WHILE IN THE HOSP, THE CUSTOMER ALSO EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 302 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. FOUND AN ALARM IN THE ALARM HISTORY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TEST. 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-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization