BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4854852 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-66596
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 30, 2015
    Report Date
    May 30, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. NO SCROLLING NUMBERS ANOMALY NOTED. THE PUMP ALSO HAD CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, AND A MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR INSULIN PUMP ALARMED BUTTON ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD HAVE LED TO THE ISSUE. THE CUSTOMER WAS INFORMED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS. A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398203 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR