BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230930 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48307
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP'S OPERATING CURRENTS WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY ALARMS NOTED. ALL BUTTONS RESPONDING PROPERLY. HOWEVER, MOISTURE DAMAGE WAS FOUND AT KEYPAD TRACES. NO DISPLAY RAMPING ON ITS OWN ANOMALY NOTED. NO TRACES OF MOISTURE WERE NOTED AT ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE.

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S MOTHER THAT THE CUSTOMER HAD A KEYPAD ANOMALY AND A SCROLL WRAP SAFETY NOTICE. CUSTOMER'S MOTHER IS VERY CONCERNED SINCE HER DAUGHTER IS 7 YEARS OLD NOW AND IS LEARNING HOW TO USE THE PUMP ON HER OWN WHILE AT SCHOOL. CUSTOMER'S MOTHER MENTIONED THAT SHE WAS ATTEMPTING TO CHANGE HER DAUGHTER'S BASAL RATES AT THE DOCTOR'S OFFICE, BUT SHE WAS EXPERIENCING KEYPAD ISSUES. CUSTOMER'S MOTHER WAS TRYING TO PROGRAM HER DAUGHTER'S BASAL RATES, BUT THE NUMBERS ON THE SCREEN KEPT SKIPPING UP. IT WAS FOUND THAT THE CUSTOMER FELL AT SCHOOL ON THE CONCRETE WHILE WEARING THE PUMP LAST MONTH. DURING TROUBLESHOOTING, CUSTOMER'S MOTHER STATED THAT SHE SMELLED INSULIN IN THE RESERVOIR CAMBER. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713233 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH B1523NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR