BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920820 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86542
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP UNABLE TO PRIME DURING THE PRIME TEST DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. NO A33 ALARM NOTED DURING TESTING. INSULIN PUMP RECEIVED WITH MINOR SCRATCH ON DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING AN ALARM ON THE INSULIN PUMP. THE BLOOD GLUCOSE WAS 215 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE AND CHECK THE DRIVE SUPPORT CAP. UPON INSPECTION THE CUSTOMER NOTICED THAT IT WAS PROTRUDED. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND TO REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398429 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR