BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200633 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42747
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED RAMPING NUMBERS NOTED. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    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

    IT WAS REPORTED BY THE CUSTOMER'S FATHER, THAT THE NUMBERS ON THE INSULIN PUMP SCROLL UP, WITH OUT ANY INPUT FROM THE CUSTOMER. TROUBLESHOOTING OCCURRED. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679174 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR