BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223782 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46934
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RECEIVED WITH INTERMITTENT ESC AND ACT BUTTON RESPONSE, DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMED NOTED DURING TESTING. INSULIN PUMP RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER RECEIVED A BUTTON ERROR ALARM ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 210 MG/DL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD HAVE LED TO THE ISSUE. THE CUSTOMER WAS INFORMED THAT THE 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. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706045 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR