BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920856 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86549
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A PROTRUDED DRIVE SUPPORT DISK, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP IS STICKING OUT OF THE PUMP. CUSTOMER STATED THAT WHEN HE WENT TO FILL THE TUBING AND IT SHOT OUT QUICKLY. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 278 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398434 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR