BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3051704 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92498
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS PROGRAMMED AND MONITORED FOR ONE DAY WITH NO BASAL ANOMALY. THE DEVICE WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. ALL BOLUSES DELIVERED PROPERLY, AND NO BOLUS ANOMALY NOTED. THE UNIT PASSED THE DISPLACEMENT, BASIC OCCLUSION, AND SELF TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO MOTOR ALARM NOTED. HOWEVER, THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. THE MOTOR PASSED THE MOTOR TEST. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME FILL ANOMALY. THE DEVICE HAD A SEVERELY SCRATCHED WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. DAYS LATER, THE MOTHER CALLED BACK AND STATED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM WITH DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 357MG/DL BEFORE ARRIVING IN THE FACILITY. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152393 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization