BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942794 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04446
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR, CLEARED ALARMED, AND THEN ALARMED BATTERY OUT LIMIT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 121 MG/DL. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE ALARMS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER STATED HE DIDN'T HAVE A BACK UP PLAN. TROUBLESHOOTING WAS PERFORMED FOR BATTERY OUT LIMIT. INFORMED THE CUSTOMER THE ALARM MAY INDICATE A LOOSE BATTERY CAP. CUSTOMER WAS ADVISED TO DISCONNECT, REMOVE RESERVOIR AND REWIND. ASSISTANCE PROVIDED WITH REPROGRAMMING TIME, DATE, AND FIXED PRIME ON THE DEVICE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419857 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR