BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3183256 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-94936
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH THE INSULIN PUMP. THE MOTHER STATED THAT THE TEACHER AT THE SCHOOL STATED THAT THE INSULIN PUMP ACCIDENTALLY DID AN OVER CORRECTION. ALSO, THE SCHOOL NURSE WROTE A NOTE INDICATING THAT THE DEVICE WAS NOT PHYSICALLY ON, AND WHEN SHE BOLUSED FOR A CORRECTION IT GAVE HER TOO MUCH INSULIN. THE MOTHER MENTIONED THAT THEY HAD LOW BATTERY SEVERAL TIMES AND THE BATTERY WAS CHANGED, BUT THE INSULIN PUMP DID NOT FUNCTION. THEN THE CALLER CHANGED AGAIN THE BATTERY AND THE DEVICE DID FUNCTION. REVIEWED THE ALARM BATTERY AND FOUND LOW BATTERY, MOTOR ERROR, AND NO DELIVERY ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282603 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 11 YR