BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860583 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67633
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    April 2, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE PHYSICAL DAMAGE OF INSULIN PUMP. CUSTOMER REPORTED THAT WHEN CHANGING BATTERIES, IT WAS NOTICED THAT BATTERY CAP LIP WAS CRACKED. CUSTOMER ALSO REPORTED THAT DISPLAY SCREEN WAS BLANK. CUSTOMER DOES NOT KNOW HOW DAMAGE OCCURRED. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. AFTER TROUBLESHOOTING, CUSTOMER STATES THAT SCREEN DISPLAY WAS STILL BLANK. CUSTOMER REPORTED THAT INSULIN WAS WORKING INTERMITTENTLY. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402764 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR