BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252102 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52741
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLANK DISPLAY, DUE TO CORRODED BATTERY TUBE. UNABLE TO VERIFY BATTERY OUT OF LIMIT ALARM, DUE TO BLANK DISPLAY. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP STOPPED WORKING AFTER HE DROPPED IT ON THE FLOOR AND IT WENT OFF. CUSTOMER STATED THAT THERE WAS NO SIGN OF ANYTHING AND NO ICONS ON THE TOP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 110 MG/DL. CUSTOMER DROPPED THE PUMP IN THE BATHROOM. CUSTOMER PUT IN A NEW BATTERY AFTER THE SCREEN WENT BLANK AND IT STILL DIDN'T COME ON. CUSTOMER STATED THAT THE CONTACT LOOKS MASHED DOWN, BUT HE THINKS HE HAS ANOTHER BATTERY CAP. CUSTOMER'S OTHER BATTERY CAP DID NOT LOOK DIFFERENT AND DID NOT WORK. CUSTOMER WAS ADVISED TO CLEAN THE BATTERY CAP CONTACTS, BUT CUSTOMER DID NOT COME BACK ON THE LINE. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURN. 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
    736734 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR