BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933409 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87054
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWER UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES WERE NOTED. NO DAMAGE TO THE CONNECTOR AND LCD INSOLATION TAPE NOTED. UNABLE TO PRIME DURING PRIME TEST DUE TO FORCE SENSOR DAMAGE BY MOISTURE. THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO DISPLAY RAMPING ON IT'S OWN NOTED. THE INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREADS, SEVERELY SCRATCHED LCD WINDOW AND BLEEDING UPPER PORTION OF THE LCD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD UNRESPONSIVE KEYS AND AN UNRESPONSIVE KEYPAD. THE CALLER STATED THAT THEY REMOVED THE BATTERIES FROM THE DEVICE AND PUT THEM BACK IN, BUT THE DEVICE DID NOT TURN ON. THE CALLER STATED THAT THEY REMOVED THE BATTERIES AGAIN WHICH CAUSED A BUTTON ERROR ALARM AND THE NUMBERS STARTED RAMPING UP ON THEIR OWN. THE CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND TO REVERT TO A BACK-UP PLANE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409515 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 17 YR