BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2170671 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01698
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED UNEXPLAINED LOW BLOOD GLUCOSE LEVELS FOR THE PAST MONTH. THE MOTHER ALSO REPORTED THAT THE CUSTOMER WAS HOSPITALIZED LAST MONTH DUE TO HIGH BLOOD GLUCOSE LEVELS. THE MOTHER DID NOT KNOW THE EXACT DATE OR BLOOD GLUCOSE READING AT THE TIME OF THE EVENT, BUT STATED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE APPROXIMATELY 400 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS CORRECT, AND THE INSULIN PUMP HAD NOT BEEN EXPOSED TO HIGH MAGNETIC FIELDS. THE MOTHER WAS NOT COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. 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 11 YR Hospitalization