BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210414 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37301
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 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

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. INSULIN PUMP PASSED BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS.

    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

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 196 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647346 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR