BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110507 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-26939
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED. THE UP ARROW BUTTON DID NOT RESPOND DUE TO CORRODED KEYPAD TRACES. NO NUMBER SCROLLING ANOMALY WAS NOTED ON THE DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND A CRACKED RESERVOIR TUBE.

    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 A BUTTON ERROR ALARM. CUSTOMER STATES THAT THE NUMBERS KEEP RAMPING UP AND THE INSULIN PUMP IS VIBRATING. THE BLOOD GLUCOSE READING IS 130 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591666 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR