BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3903530 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86389
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 10, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED SCREEN, CRACKED RESERVOIR TUBE, BROKEN RESERVOIR TUBE LIP, MISSING RESERVOIR TUBE LIP O-RING, CRACKED BATTERY TUBE THREADS, MISSING END CAP STICKER, AND LOOSE/PROTRUDED DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING ISSUES WITH THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 212MG/DL. THE CALLER STATED THAT THE DEVICE SEEMS TO BE WORKING, BUT HE WAS NOR RECEIVING ANY INSULIN. HE STATED THAT A PIECE OF PLASTIC AND THE BLACK RUBBER RING IN THE RESERVOIR COMPARTMENT CAME FROM THE INSULIN PUMP; IT HAPPENED WHEN HE WAS ATTEMPTING TO LOCK THE RESERVOIR INTO PLACE. 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
    379395 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR