BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4213421 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37244
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT EVALUATED YET. FURTHER INFO 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. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP, AND A CRACKED RESERVOIR TUBE. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S FATHER THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THEIR INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 133 MG/DL. CUSTOMER WAS RUNNING CROSS COUNTRY AND IT WAS RAINING. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTION. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647416 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR