BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4780745 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57453
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 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

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS BUT DID NOT RECEIVE A LOW RESERVOIR ALARM FROM THEIR INSULIN PUMP. THE CUSTOMER STATED THAT THE LOW BLOOD GLUCOSE IS A COMMON OCCURRENCE AND INQUIRED WHEN THEY WERE ELIGIBLE FOR AN UPGRADE ON THEIR INSULIN PUMP. THE CUSTOMER DID NOT MENTION ANY FORM OF TREATMENT FOR THE LOW BLOOD GLUCOSE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325428 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR