BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190446 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41130
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTION PROPERLY. NO BUTTONS ANOMALY WHEN SELECTING MAIN MENU. THE DEVICE WAS PROGRAMMED WITH MULTIPLE BOLUS UNITS AND ALL PROPERLY RECORDED IN DEVICE HISTORY SCREEN. THE INSULIN PUMP FUNCTIONED PROPERLY. NO BOLUS OR HISTORY ANOMALY NOTED DURING TESTING. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. NO COMPROMISED FORCE SENSOR SYSTEM ALARMS NOTED DURING TESTING. THE DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 SHE WAS ATTEMPTING TO CHANGE HER INFUSION SET AND THE INSULIN PUMP ALARMED DURING REWIND AND PRIME SEQUENCE. CUSTOMER'S BLOOD GLUCOSE WAS 156 MG/DL. CUSTOMER REPORTED SHE CANNOT GET PAST THE REWIND. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. ALARM REOCCURRED WHEN CUSTOMER WAS ASKED TO REWIND. CUSTOMER WAS ADVISED TO REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667912 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR