BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240591 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49765
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED DURING SELF-TEST DUE TO FAULTY CONNECTOR ON REMOTE FREQUENCY BOARD. NO BLACK SCREEN, BUZZING OR AUDIO OR BEEP ANOMALY NOTED. INSULIN PUMP FUNCTIONED PROPERLY DURING REWIND AND BASIC OCCLUSION, OCCLUSION, PRIME, THE EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST. NO EXCESSIVE NO DELIVERY ALARM NOTED DURING TESTING. INSULIN PUMP WAS TESTED WITH WATER LIQUID IN RESERVOIR. THE RESERVOIR VOLUME AND INSULIN PUMP STATUS SCREEN MATCHED PROPERLY. INSULIN PUMP WAS PROGRAMED TO ALARMED LOW RESERVOIR AND LOW RESERVOIR ALARM FUNCTIONED PROPERLY. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    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 THAT THE INSULIN PUMP RETURNED AN ERROR ALARM EVERY DAY FOR A WEEK LEADING UP TO THE CALL. CUSTOMER REPORTED THAT THE INSULIN PUMP'S SCREEN SHOWED NUMBERS COUNTING FROM ONE TO SEVEN, THEN THE SCREEN WENT BLACK. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP DISPLAYED A MESSAGE THAT THE RESERVOIR WAS EMPTY, BUT THE RESERVOIR WAS ACTUALLY FULL. BLOOD GLUCOSE LEVEL WAS 47 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED TREATING WITH JUICE AND FOOD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723776 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR