BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190294 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01787
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 STATED THAT SHE WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS OVER 1000 MG/DL AFTER RECEIVING A REPLACEMENT INSULIN PUMP. PRIOR TO BEING HOSPITALIZED, THE CUSTOMER HAD CALLED IN FOR ASSISTANCE IN PROGRAMMING THE REPLACEMENT INSULIN PUMP. THE CUSTOMER STATED THAT SHE WAS TREATING HER BLOOD GLUCOSE LEVELS BY USING THE EASY BOLUS FEATURE. THE CUSTOMER DID NOT REALIZE THAT THE FACTORY SETTING FOR THE EASY BOLUS WAS 0.1. THE CUSTOMER THOUGHT, SHE WAS GIVING HERSELF 1.0 UNIT BOLUSES, CAUSING HER BLOOD GLUCOSE LEVELS TO ELEVATE DUE TO NOT GETTING ENOUGH INSULIN. 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-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization