BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6216283 · Received December 30, 2016

    Report

    Report Number
    2032227-2016-55846
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    December 5, 2016
    Report Date
    March 18, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED UNABLE TO PRIME DURING PRIME TEST DUE TO LOOSE PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP AND CRACKED LCD WINDOW.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 480 MG/DL. THE CUSTOMER TREATED THEIR BLOOD GLUCOSE LEVELS WITH MANUAL INJECTIONS. CUSTOMER STATES INSULIN IS "SQUIRTING OUT" DURING THE MANUAL PRIME PROCESS. CUSTOMER STATES THEY ARE UNABLE TO EXIT THE "PREPARING TO PRIME" LOOP. CUSTOMER STATES THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN AFTER TROUBLESHOOTING. THE CUSTOMER WAS SENT A REPLACEMENT INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866052 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other