BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3791305 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84232
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. A SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP KEPT ALARMING WHILE PRIMING AND INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS. THE BLOOD GLUCOSE READING WAS 165MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS STICKING OUT. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267483 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR