BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4260248 · Received November 18, 2014

    Report

    Report Number
    2032227-2014-53885
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    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

    NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. HOWEVER, THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO DISPLAY ANOMALY WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND A SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER STATED THAT WHEN HE WENT TO ENTER HIS CARBS, THE NUMBERS RAMPED UP. THE CUSTOMER REMOVED THEN REINSERTED HIS INSULIN PUMP'S BATTERY AND RECEIVED A BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 88 MG/DL. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746327 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR