BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2970579 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91211
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DELIVERED A BOLUS WITHOUT HIS INTERVENTION, AND IT HAPPENED TWICE. THE BLOOD GLUCOSE READING WAS 47MG/DL. THE CUSTOMER STATED THAT THE INCIDENTS OCCURRED WHILE WATCHING TV. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS NOT CONNECTED WHILE COMPLETING AN INFUSION SET CHANGE. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE CUSTOMER ALSO STATED THAT WHEN HE WAS CHECKING THE ALARM HISTORY, THE SCREEN WOULD FREEZE AND HE WAS NOT ABLE TO GO THRU THE REST OF THE DEVICE'S HISTORY. THE SELF TEST WAS PERFORMED AND PASSED. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74386 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 50 YR