BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933297 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87037
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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

    IT WAS REPORTED THAT THE INSULIN PUMP RECEIVED MULTIPLE ALARMS AND THAT THE DISPLAY SCREEN WENT BLANK. THE BLOOD GLUCOSE READING WAS 161 MG/DL. THE CUSTOMER STATED THAT THIS IS THE SECOND OCCURRENCE OF AN OFF NO POWER ALARM WITHOUT A LOW BATTERY WARNING. IT WAS CONFIRMED THAT A FRESH SET OF THE RECOMMENDED BATTERY WAS INSERTED. THE DEVICE WAS NOT DROPPED NOR BUMPED. NO UNATTENDED ALARMS WERE OBSERVED. ADVISED DISCONTINUATION OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409154 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR