BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123047 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29581
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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 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 SHE WAS CHANGING HER INFUSION SET, WAS GOING TO FILL THE CANNULA AND NOTICED THE INSULIN PUMP WAS OFF. CUSTOMER CHANGED OUT BATTER AND DEVICE DID NOT TURN BACK ON. CUSTOMER'S BLOOD GLUCOSE WAS 436 MG/DL. CUSTOMER STATED THE DEVICE DID NOT HAVE PHYSICAL DAMAGE. THE DEVICE WAS NOT DROPPED OR BUMPED. CUSTOMER REPORTED SHE DOES SWEAT AND WEARS THE DEVICE IN HER BRA, BUT HASN'T SWEATED RECENTLY, WHEN ASKED IF THE DEVICE WAS EXPOSED TO MOISTURE. THE BATTERY CAP, BATTERY COMPARTMENT, OR SPRING WERE NOT DAMAGED NOR CORRODED. CUSTOMER WAS ADVISED TO REINSERT A NEW BATTERY AND THE DISPLAY DID RETURN. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601125 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR