BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4851218 · Received June 17, 2015

    Report

    Report Number
    2032227-2015-19231
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    December 29, 2014
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED BLANK DISPLAY NOTED. THE DEVICE WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. BASIC OCCLUSION, AND OCCLUSION TEST WERE NOT PERFORMED DUE TO PRIME ANOMALY. THE DEVICE ALARMED DURING SELF-TEST DUE TO FAULTY CONNECTOR ON RADIO FREQUENCY BOARD. THE DEVICE HAD HAD MINOR SCRATCHES ON THE LCD WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP RANDOMLY TURNS OFF AND TIME AND DATE WOULD NEED TO BE REPROGRAMMED. CUSTOMER'S BLOOD GLUCOSE WAS 130 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT CUSTOMER RECEIVED A FEW FAILED SELF-TEST ALARMS. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393313 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR