BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942370 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87612
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED BASIC OCCLUSION TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS WERE NOTED. UNABLE TO PRIME INSULIN PUMP DURING PRIME TEST DUE TO SLIGHTLY LOOSE DRIVE SUPPORT DISK. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. INSULIN PUMP RECEIVED WITH SEVERELY SCRATCHED LCD WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE MEDWATCH REPORT 3004209178-2014-87625.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS. THE CUSTOMER STATED THAT IN THE PAST THERE WERE NO DELIVERY ALARMS. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS 237 MG/DL. THE CUSTOMER STATED THAT THE DEVICE WAS ON THEIR SHOULDER WHEN THEY HAD AN MRI. THE CUSTOMER IS NOT USING THE SENSOR FEATURE. THEY ARE ABLE TO REWIND THE DEVICE. THE CUSTOMER STATED THAT THE DEVICE ALERTED NO INSULIN BUT THE CUSTOMER CHECK AND THERE WERE 100 UNITS OF INSULIN IN THE RESERVOIR. THE DRIVE SUPPORT CAP WAS RECESSED. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419741 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR