BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFSUIN PUMP

    MDR report key: 4130078 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24513
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, BROKEN BATTERY TUBE THREADS, BROKEN RESERVOIR TUBE LIP, MISSING RESERVOIR O-RING AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP KEPT ALARMING BUTTON ERROR. THE CUSTOMER STATED THAT THE DEVICE HAD BEEN BROKEN A LONG TIME AGO. THE CUSTOMER'S BLOOD GLUCOSE WAS 111 MG/DL. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579217 PARADIGM REAL-TIME REVEL INSULIN INFSUIN PUMP OYC MEDTRONIC MINIMED MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR