BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130808 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94094
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER, ROBERT CALLED TO A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER CURRENT BLOOD GLUCOSE READING IS 293 MG/DL. CALLER STATED THAT THE PARAMEDICS WERE CALLED TO TREAT LOW BLOOD GLUCOSE, THEN TRANSPORTED TO HOSPITAL. CUSTOMER'S BLOOD GLUCOSE READING AT TIME OF EVENT WAS 126 MG/DL. CALLER STATED THAT INSULIN PUMP OVER DELIVERED. THE INSULIN PUMP DELIVERED A BOLUS THAT WAS NOT PROGRAMMED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231668 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization