BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210098 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44580
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. 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. SEE MEDWATCH 2032227-2014-44578 AND 2032227-2014-44579.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER ISSUES WITH THEIR TRANSMITTER AND SENSOR ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 20 MG/DL. THE CUSTOMER STATES THAT THE SENSOR DID NOT DETECT THE LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED AND TRANSFERRED TO THE EMERGENCY ROOM ON (B)(6) 2014 AM. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING BY TURNING ON THE SENSOR FEATURE AND PERFORMING SELF TESTS. THE CUSTOMER WAS ADVISED TO MONITOR THE DEVICE FOR ANY FURTHER ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692945 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR