BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252047 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52697
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 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

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE RECEIVED AN OFF NO POWER ALARM ONE HOUR AFTER A WEAK BATTERY ALERT. CUSTOMER STATES THE BATTERY CAP IS NOT LOOSE, CRACKED OR DAMAGED. CUSTOMER ALSO STATED THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART DURING PRIME. SELF TEST PERFORMED AND PASSED. CUSTOMER WAS ADVISED TO CLEAN THE BATTERY CAP AND INSERT A NEW BATTERY AND CALL BACK IF ISSUE RECURS. BLOOD GLUCOSE VALUE IS 110 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737845 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 54 YR