BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3251042 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96136
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOLUS WIZARD AMOUNT WERE OVERRIDDEN AND THE CUSTOMER WAS NOT DOING THAT. THE MOTHER ALSO STATED THAT THE INSULIN PUMP GAVE A BOLUS AT NIGHT WITHOUT HIS INTERVENTION. THE CALLER MENTIONED THAT THE DEVICE ALARMED NO DELIVERY MULTIPLE TIMES. AFTER REVIEWING THE REPORT TWO DAYS, IT SHOWED THAT THE CUSTOMER USED THE BOLUS WIZARD SEVEN TIMES, AND IT WAS ONLY ONE TIME WHERE IT SHOWS THE INSULIN ESTIMATE DELIVERY AMOUNT WAS CHANGED. THE CUSTOMER REQUESTED A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352032 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 12 YR