BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982051 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89809
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 RECEIVED WITH NO ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACE. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MISSING END CAP STICKER. NO MOISTURE DAMAGE INSIDE INSULIN PUMP NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT A BUTTON WAS NOT WORKING ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 217 MG/DL AT THE TIME THE ISSUE WAS REPORTED. THE CUSTOMER' S MOTHER STATED THAT THE INSULIN PUMP MIGHT HAVE BEEN EXPOSED TO MOISTURE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456567 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS A6523NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR