BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4122982 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29520
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY AND THE ISSUE COULD NOT BE RESOLVED BY SEVERAL INFUSION SET CHANGES. THE CUSTOMER STATED THAT SHE HAD CHANGED THE INFUSION SET 3 TIMES AND THAT SHE COULD NOT GIVE INSULIN ABOVE 1 UNIT. SHE DID NOT KNOW THE BLOOD GLUCOSE READING. SHE ADVISED THAT SHE WOULD CALL BACK WHEN SHE HAD THE INSULIN PUMP AVAILABLE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600836 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR