BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120026 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29261
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    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.SEE MEDWATCH NUMBER 2032227-2014-29180 UNDER RESERVOIR.

    Description of Event or Problem · 1

    CUSTOMER WAS GETTING A LOW RESERVOIR AND UNABLE TO GIVE HER SELF A BOLUSBUT DIDN'T KNOW HOW TO CLEAR ALARMS. I EXPLAINED HOW TO CLEAR THE ALARMAND CHECK UNITS LEFT IN THE STATUS SCREEN. CUSTOMER REPORTED SHE WAS RECEIVING MULTIPLE LOW RESERVOIR ALARMS ON THE INSULIN PUMP. CUSTOMER STATED SHE WAS UNABLE TO GIVE HER SELF AN INSULIN BOLUS AND DIDN'T KNOW HOW TO CLEAR THE ALARMS. CUSTOMER WAS ASSISTED IN CLEARING THE ALARM AND TO CHECK THE INSULIN UNITS LEFT IN THE STATUS SCREEN. CUSTOMER ALSO REPORTED THAT INSULIN WAS NOT EXITING THE TUBING DURING PRIME AND THERE WAS AN ABSENCE OF NO DELIVERY ALARM. BLOOD GLUCOSE LEVEL WAS 138 MG/DL. CUSTOMER REPORTED CHANGING THE INFUSION SET AND RESERVOIR AND THAT INSULIN EXITED NORMALLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597375 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB A000290053

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR