BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4111453 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27613
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOWN ARROW BUTTON DID NOT RESPOND DUE TO CORRODED KEYPAD TRACES. NO BATTERY OUT LIMIT ALARMS COULD BE VERIFIED DUE TO THE UNRESPONSIVE BUTTONS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, AND A CRACKED RESERVOIR TUBE LIP.

    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

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BATTERY OUT LIMIT AFTER BATTERY CHANGE. CUSTOMER STATED THE BATTERIES WERE OUT GREATER THAN DURATION ALLOWED BY THE INSULIN PUMP. CUSTOMER STATED SHE TRIED PRESSING THE ESC AND ACT BUTTONS TO CLEAR THE ALARM AND THE DEVICE DID NOT RESPOND. BLOOD GLUCOSE VALUE 87 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590600 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH A000205315

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR