BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4002435 · Received August 12, 2014

    Report

    Report Number
    2032227-2014-07412
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS WERE NOTED. NO DISPLAY RAMPING ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNERS, DISPLAY WINDOW AND BATTERY TUBE THREADS, AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE NUMBERS ON THE INSULIN PUMP'S SCREEN WERE RAMPING ON THEIR OWN. BLOOD GLUCOSE LEVEL WAS 146 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477547 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL A000290380

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR