BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4111135 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-23015
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    December 20, 2013
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, BROKEN RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP HAD A CRACKED RESERVOIR COMPARTMENT AND MISSING PLASTIC FROM THE RING AROUND THE COMPARTMENT. BLOOD GLUCOSE READING WAS 146 MG/DL. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592066 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR