BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4150336 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35138
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 22 MMOL/L AT THE TIME OF ENTRY INTO THE AMBULANCE, AND AFTER TREATMENT WITH AN MANUAL INJECTION, THE BLOOD GLUCOSE READING DURING THE CALL WAS 14.3 MMOL/L. THE REPORTER STATED THAT THE CUSTOMER HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVELS ALL DAY AFTER AN INFUSION SET CHANGE. THE CUSTOMER ALSO HAD AN INFECTION. THE CUSTOMER WAS TAKEN OFF OF INSULIN PUMP THERAPY UPON ADMITTANCE INTO THE HOSPITAL. A BENT INFUSION SET CANNULA WAS FOUND. ADVISED RETURN OF THE INFUSION SET FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629808 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization