BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945950 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04754
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    CUSTOMER'S MOTHER CALLED TO REPORT AN ALARM ON HER DAUGHTER'S INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 600 MG/DL. THE MOTHER STATED THAT THE ALARM OCCURED AFTER THE BATTERY WAS CHANGED. TROUBLESHOOTING WAS PERFORMED. DURING TROUBLESHOOTING IT WAS DISCOVERED THAT THE BATTERIES WERE LEFT OUT OF THE INSULIN PUMP GREATER THAN THE DURATION ALLOWED. ADVISED CUSTOMER'S MOTHER THAT THIS BEHAVIOR IS TO BE EXPECTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425516 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR