BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974007 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89008
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    CUSTOMER'S MOTHER REPORTED RECEIVING A NO DELIVERY ALARM ON THE CUSTOMER'S INSULIN PUMP. SHE STATED THAT THE CUSTOMER WENT TO BED WITH A LOW RESERVOIR ALARM AND WOKE UP WITH A NO DELIVERY ALARM. THE BLOOD GLUCOSE READING WAS 418 MG/DL, AND AFTER CHECKING AGAIN WAS UP TO 462 MG/DL. CUSTOMER'S MOTHER WAS ADVISED TO DISCONNECT AND THEN RECONNECT THE TUBING TO THE RESERVOIR AND MANUALLY PUSH THE PLUNGER VERY SLOWLY AND VERIFY IF INSULIN EXITED THE TUBING. SHE STATED THAT THE INSULIN DID EXIT AND THE INSULIN PUMP DID NOT ALARM FOR NO DELIVERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450593 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 12 YR