BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090507 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23155
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD BROKEN RESERVOIR TUBE LIP, A MISSING RESERVOIR TUBE O-RING AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE OUTTER RING INSIDE THE RESERVOIR COMPARTMENT WAS BROKEN. BLOOD GLUCOSE READING WAS 106 MG/DL. CUSTOMER DID NOT RECALL HOW THE DAMAGE OCCURRED. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570241 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR