BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841655 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85256
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    December 1, 2013
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    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

    INSULIN PUMP WAS RECEIVED WITH A FULL SEGMENT DISPLAY FOLLOWED BY A BLANK DISPLAY. UNABLE TO VERIFY A FROZEN SCREEN DUE TO A BLANK DISPLAY. NO CONSTANT TONE OBSERVED DURING ANALYSIS. A CRACKED DISPLAY, SCRATCHED LCD WINDOW, BROKEN RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MISSING END CAP STICKER AND BLEEDING LCD CLASS ALSO NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED BECAUSE THE INSULIN PUMP STARTED BEEPING AND THEN SHUT COMPLETELY OFF. HER BLOOD GLUCOSE READING IS 57 MG/DL. TREATED WITH JUICE AND FOOD. SHE STATED THAT HER BLOOD GLUCOSE LEVEL IS LOW BECAUSE SHE HAD GONE A LONG PERIOD OF TIME WITHOUT EATING. CUSTOMER ALSO STATED THAT THE DISPLAY WAS FROZEN. AFTER THE BATTERY WAS REINSERTED, THE INSULIN PUMP WAS STILL FROZEN WITH NO ADVANCEMENT OF TIME. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318233 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 18 YR