BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974018 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89021
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS MONITORED FOR 24 HOURS WITH 2.0 BASAL RATE. THE DEVICE DID FUNCTION PROPERLY. NO BLANK DISPLAY OR DISPLAY ANOMALY NOTED. ALL THE OPERATING CURRENTS WERE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARM NOTED. NO DAMAGE INSIDE THE INSULIN PUMP NOTED. THE UNIT WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND 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

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE BLOOD GLUCOSE READING 127 MG/DL. THE CUSTOMER STATED THAT SHE RECEIVED A LOW BATTERY ALERT, AND AFTER CHANGING THE BATTERY OUT, NOTHING HAPPENED. SHE ATTEMPTED AGAIN AND STATED THAT THE DEVICE RESORTED TO A BLANK SCREEN. SHE TRIED AGAIN WITH NEW BATTERIES, GOT THE INSULIN PUMP TO WORK, BUT THEN IT HAD A BLANK DISPLAY AGAIN THE NEXT DAY. THE SAME THING HAPPENED ONCE AGAIN THEREAFTER. THE CUSTOMER CONFIRMED THAT NO CORROSION WAS OBSERVED AND THAT THE DEVICE HAD NOT BEEN DROPPED NOR BUMPED. UPON TROUBLESHOOTING, THE DISPLAY DID NOT RETURN. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450760 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR