BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4646362 · Received March 31, 2015

    Report

    Report Number
    3004209178-2015-45619
    Event Type
    Injury
    Date Received
    March 31, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACE. THE INSULIN PUMP FUNCTIONED PROPERLY DURING REWIND AND BASIC OCCLUSION, OCCLUSION, PRIME, THE EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A KEYPAD ANOMALY. THE CUSTOMER STATED THEIR BUTTONS WERE UNRESPONSIVE. THE CUSTOMER COULD NOT NAVIGATE THROUGH THEIR MENU AS A RESULT. CUSTOMER'S BLOOD GLUCOSE DECLINED TO 25 MG/DL. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212519 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR