BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3200279 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02671
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    September 1, 2012
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 PHONE CALL WAS MADE TO THE CUSTOMER IN ORDER TO FOLLOW UP ON A PREVIOUS CALL SHE HAD MADE FOR LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE HAS BEEN HOSPITALIZED FIVE TIMES SINCE (B)(6) 2012. THE CUSTOMER COULD NOT RECALL ANY DATES. THE CUSTOMER STATED THAT FOUR OF THE FIVE HOSPITALIZATIONS WERE DUE TO HIGH BLOOD GLUCOSE LEVELS. THE FIFTH EVENT WAS FOR LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER DECLINED TO CONDUCT TROUBLESHOOTING AS SHE DIDN'T FEEL THAT ANY OF THE EVENTS WERE INSULIN PUMP RELATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298412 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization