BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3943050 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87727
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED BUTTON ERROR ALARM DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE DEVICE HAD MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BELT CLIP SLOT, BROKEN RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT SWIMMING THE INSULIN PUMP ATTACHED. THE CUSTOMER'S BLOOD GLUCOSE WAS 279 MG/DL WHICH WAS TREATED WITH A MANUAL INJECTION. THE CALLER STATED THAT MOISTURE IS SEEN INSIDE AND WHEN THE BUTTONS ARE PUSHED WASTER COMES OUT OF THE DEVICE. THE CALLER STATED THAT THE CUSTOMER FEELS OKAY. THEY ALSO STATED THE REASON FOR THE HIGH BLOOD GLUCOSE WAS THE INSULIN NOT BEING FULLY ABSORBED AFTER EATING. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419220 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR