BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230942 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48322
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 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
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED LOW RESERVOIR ALARM NOTED. LOW RESERVOIR ALARM FUNCTIONED PROPERLY DURING TESTING. INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE ON THE UP ARROW BUTTON DUE TO CORRODED KEYPAD TRACES NOTED. INSULIN PUMP HAD A CRACKED CASE AT LCD WINDOW CORNER, CRACKED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT AND STAINED END CAP STICKER.

    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 THAT THE CUSTOMER HAD A KEYPAD ANOMALY ON THE INSULIN PUMP. CUSTOMER WAS CALLING BECAUSE HER BUTTONS ON THE PUMP WERE UNRESPONSIVE. CUSTOMER STATED THAT THERE WAS A CRACK IN THE CASE OF THE INSULIN PUMP AND THERE WAS A LOW RESERVOIR ALERT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 225 MG/DL. CUSTOMER STATED THAT THERE WAS NOTHING UNUSUAL AND NO EXPOSURE TO MOISTURE. CUSTOMER REPORTED THAT THERE WAS A CRACK IN THE RIGHT CORNER OF THE DISPLAY AND IT GOES TO THE TOP. CRACK IS ABOUT 1 ¼ INCHES LONG. CUSTOMER STATED THAT SHE CAN READ THE PUMP SCREEN. 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
    713281 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR