BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3760167 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-83801
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 2, 2014
    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

    MOISTURE DAMAGE ON THE KEYPAD TRACES NOTED BUT ALL BUTTONS FUNCTIONED PROPERLY. NO UNEXPECTED NUMBERS RAISING DURING TESTING. INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS. A STRIPPED BATTERY CAP, CRACKED CASE, CRACKED RESERVOIR TUBE LIP, AND SCRATCHED LCD WINDOW NOTED.

    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 RETURN 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING WAS OVER 400 MG/DL. CALLER STATED THAT THE CUSTOMER'S INFUSION SET WAS KINKED CAUSING THE HIGH BLOOD GLUCOSE. CALLER STATED THAT THE CUSTOMER WAS HOSPITALIZED TWO OTHER TIMES, SIX MONTHS AGO AND TWO WEEKS AGO. CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP WAS MALFUNCTIONING STATED THE NUMBERS GO UP AND DOWN WITHOUT INPUT FROM THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237040 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization