BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3143626 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94317
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    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

    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 INSULIN PUMP ALARMED MOTOR ERROR WHILE DRIVING. THE CALLER STATED THAT HE HAD 20.0 UNITS OF INSULIN LEFT IN THE INSULIN PUMP, AND THE DEVICE HAS DELIVERED THE REST OF INSULIN INTO HIS BODY. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 264MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE ALARM HISTORY REVEALED MOTOR ERROR, LOW RESERVOIR AND MULTIPLE BATTERY ALARMS. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. PERFORMED THE DISPLACEMENT AND SELF TEST AND THEY PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244640 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR