BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3110125 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01808
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    CUSTOMER CALLED TO REPORT HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT TIME OF EVENT WAS 32 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 182 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT ALERTING CUSTOMER ABOUT THE LOW BLOOD GLUCOSE. THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP DURING THE REWIND/PRIME SEQUENCE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210943 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization