BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6155026 · Received December 8, 2016

    Report

    Report Number
    2032227-2016-48405
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING A FAILED BATTERY TEST ON THEIR INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS INFORMED THAT (B)(6) AAA ALKALINE BATTERIES ARE MOST EFFECTIVE. THE CUSTOMER WAS ALSO INFORMED THAT BATTERIES SHOULD BE STORED AT ROOM TEMPERATURE AND BE USED WITHIN EXPIRATION DATE. THE CUSTOMER DID NOT HAVE A TUBING CLAMP TO FINISH TROUBLE SHOOTING. A TUBING CLAMP WAS SENT OUT TO THE CUSTOMER AND WAS ADVISED TO CALL BACK TO FINISH TROUBLE SHOOTING THE INSULIN PUMP ONCE THEY HAD RECEIVED THE TUBING CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805139 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other