BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210902 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44754
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED HIGH BLOOD GLUCOSE. CUSTOMER STATED SHE WAS CHANGING OUT THE RESERVOIR AND WHEN SHE PRESSED ACT IT DID NOT REGISTER ON THE INSULIN PUMP. CUSTOMER STATED THAT IT TOOK 4 SECONDS FOR IT TO REGISTER. CUSTOMER ATE PIZZA AND HER BLOOD GLUCOSE BECAME UNUSUALLY HIGH. CUSTOMER HAD KETONES AND WAITING FOR DOCTOR'S CALL. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 313 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. PERFORMED HIGH PRESSURE TEST AND TEST PASSED. IT WAS FOUND THAT DURING PRIME PROCESS CUSTOMER PRESSES THE PLUNGER UP ON THE RESERVOIR NOT CONNECTED TO ANYTHING AND FILLED WITH INSULIN. ADVISED THE CUSTOMER THIS COULD CAUSE MANIPULATION OF THE RESERVOIR WITH PRESSURIZATION. ADVISED CUSTOMER THE 2 HIGH BLOOD GLUCOSE. ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693546 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR