BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4823025 · Received June 6, 2015

    Report

    Report Number
    2032227-2015-18123
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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

    THE PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS WERE NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED LCD WINDOW, AND A SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER EXPLAINED THAT THE INSULIN PUMP WAS SCROLLING CONSTANTLY AND THEN ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 123 MG/DL. WHILE TROUBLESHOOTING, THE CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WAS INFORMED THE DEVICE WOULD BE REPLACED. THE CUSTOMER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366952 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR