BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4213338 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37247
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS WERE NOTED. THE INSULIN PUMP WAS ALSO RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND DISPLAY WINDOW AND WITH MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON HER INSULIN PUMP. CUSTOMER STATED THAT SHE WAS TRYING TO MASH THE ESC AND ACT KEYS TO CLEAR THE ALARM, BUT THEY ARE UNRESPONSIVE. CUSTOMER STATED THAT SHE MUST HAVE ROLLED OVER THE PUMP IN HER SLEEP. CUSTOMER WAS SLEEPING AT THE TIME THAT THE ALARM BEGAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 207 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648962 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR