BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4151612 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34653
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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 ALARMED FAILED BATTERY TEST DUE TO FAULTY BATTERY TUBE. OPERATING CURRENTS WAS NOT TESTED DUE TO FAULTY BATTERY TUBE. NO BATTERY OUT LIMIT ALARMS NOTED. THE DEVICE WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. THE DEVICE HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, AND CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BATT OUT LIMIT ALARM AND A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT HE WORE THE PUMP ON HIS SHIRT UNDER HIS NECK YESTERDAY. CUSTOMER STATED THAT THE PUMP WAS SECURED UNDER THE BELT OF THE SEATBELT. CUSTOMER ALSO STATED THAT HE MAY HAVE CAUSED THE ELONGATED BUTTON PRESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 180 MG/DL. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633143 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR