BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841788 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02719
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 13, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED AFTER A BATTERY CHANGE DUE TO A FAULTY CAPACITOR ON THE INTERFACE BOARD. THE DEVICE PASSED THE SELFTEST, OFF NO POWER, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATIONS AND NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS OBSERVED DURING ANALYSIS. A SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT AND CRACKED BATTERY TUBE THREADS NOTED.

    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 CALLED COMPLAINING THAT HER INSULIN PUMP IS ALARMING THAT IT'S OUT OF INSULIN, BUT THERE IS STILL ABOUT 60 UNITS LEFT. CUSTOMER STATED INSULIN PUMP OVER-DELIVERED INSULIN. SHE STATED THAT SHE HAS BEEN EXPRIENCING MANY LOW BLOOD GLUCOSE LEVELS FOR MONTHS, AND WAS IN A BAD CAR ACCIDENT RECENTLY, WHERE SHE WAS THE DRIVER. CUSTOMER ALSO STATED THAT WHEN SHE WAS GOING TO DO A SET CHANGE, THE INSULIN PUMP RESET ITSELF AND IT MADE HER REWIND THE INSULIN PUMP. THE INSULIN PUMP HAS ALARMED TWICE TODAY, BACK TO BACK. SHE WAS HOSPITALIZED ABOUT A MONTH AGO DUE TO LOW BLOOD GLUCOSE LEVELS. CUSTOMER HAS BEEN TREATING WITH FOOD. AT THE TIME OF ADMISSION, HER BLOOD GLUCOSE LEVEL WAS 30 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319124 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization