BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933100 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86907
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    NO BUTTON ERROR ALARM NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND HAD AN UNRESPONSIVE KEYPAD. THE BLOOD GLUCOSE READING WAS 214 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP GOT DAMP PRIOR TO RECEIVING THE ALARM. ADVISED DISCONTINUATION OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411177 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR