BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4842693 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-65193
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 23, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S BUTTONS WERE NOT RESPONDING. THE CUSTOMER STATED THE ESC AND ACT BUTTONS WERE NOT WORKING. THE CUSTOMER STATED THAT HE WAS UNABLE TO REWIND OR PRIME THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 387 MG/DL. THE CUSTOMER CONFIRMED THAT THE ISSUE DID NOT RESULT IN A SERIOUS INJURY OR HOSPITALIZATION. THE CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES ASIDE FROM BEING OUT IN THE SUN. THE CUSTOMER WAS ADVISED THAT THEIR INSULIN PUMP NEEDED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WAS INFORMED THE DEVICE WOULD BE REPLACED. THE CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384702 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR