BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3092944 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01648
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR THREE TO FOUR WEEKS, AND WAS HOSPITALIZED ON (B)(6) 2013. THE PARAMEDICS WERE ALSO CALLED ON (B)(6) 2013, DUE TO LOW BLOOD GLUCOSE LEVELS. THE CALLER STATED THAT THE CUSTOMER WAS EATING IN THE KITCHEN, AND THEN BEGAN ACTING "OUT OF IT". TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER HAD RECENTLY MADE CHANGES TO THE BASAL RATES. THE CALLER DID STATE THAT THE INSULIN PUMP WAS WORN DURING AN MRI. ADVISED THAT THE INSULIN PUMP SHOULD NOT BE EXPOSED TO HIGH MAGNETIC FIELDS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194762 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization