BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4841238 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-64912
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    THE CALLER REPORTED VIA PHONE CALL THAT HE HAD CHANGED THE BATTERY YESTERDAY BUT FOR SOME REASON IT IS POWERING OFF. CALLER HAS CHANGED IT AGAIN AND NOW IT HAS COME UP. CUSTOMER'S BLOOD GLUCOSE WAS 120 MG/DL. CUSTOMER WAS USING A DURACELL BATTERY. CALLER STATED THAT THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CALLER STATED THAT THE DISPLAY RETURNED. CALLER STATED THAT THEY HAD TO TIGHTEN THE CAP TO GET THE PUMP TO COME ON. CALLER WAS ADVISED TO MONITOR THE PUMP. CALLER WAS ADVISED THAT A REPLACEMENT BATTERY CAP WILL BE SHIPPED AS A COURTESY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385792 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR