BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4232018 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48455
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT UP BUTTON RESPONSE DUE TO A CORRODED KEYPAD TRACE. NO DISPLAY ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS. NO MOISTURE DAMAGE WAS NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT THE SCREEN WOULD NOT STOP SCROLLING ON THE CUSTOMER'S INSULIN PUMP. HER BLOOD GLUCOSE WAS 72 MG/DL AT THE TIME OF REPORTING. SHE STATED THAT THE PUMP IS SOMETIMES EXPOSED TO MOISTURE IN THE FORM OF WORKOUT PERSPIRATION. THE INSULIN PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715771 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR