BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2112384 · Received May 26, 2011

    Report

    Report Number
    2032227-2011-01326
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 566 MG/DL. THE CUSTOMER WAS VERY DISSATISFIED WITH THE INSULIN PUMP, AND STATED THAT SHE WANTED TO STOP INSULIN PUMP THERAPY. THE CUSTOMER LATER CALLED TO REPORT THAT HER DOCTOR WANTED THE INSULIN PUMP REPLACED. THE CUSTOMER DID NOT HAVE THE INSULIN PUMP WITH HER TO VERIFY THE SERIAL NUMBER OR TO TROUBLESHOOT. THE CUSTOMER STATED THAT SHE WOULD CALL BACK. 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-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization