BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4050102 · Received August 30, 2014

    Report

    Report Number
    2032227-2014-14603
    Event Type
    Malfunction
    Date Received
    August 30, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 180MG/DL. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531369 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR