BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3171077 · Received June 14, 2013

    Report

    Report Number
    2032227-2013-02444
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    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

    A CALL WAS MADE TO THE CUSTOMER TO FOLLOW UP ON PREVIOUS CALLS SHE MADE FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE HAS HAD TO CALL THE PARAMEDICS THREE TIMES DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WAS UNABLE TO HEAR THE INSULIN PUMP ALERTS AT THE TIME, AND HAD THE INSULIN PUMP REPLACED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP CAN BE SET TO VIBRATE. THE CUSTOMER STATED THAT SHE HAS AN APPOINTMENT WITH HER INSULIN PUMP TRAINER SOON. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271632 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention