BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3953968 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04622
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS ADMITTED TO URGENT CARE DUE TO HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 470 MG/DL AND THE CUSTOMER WAS TREATED WITH A MANUAL INJECTION. THE NURSE STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE VISIT. SHE REPORTED THAT THE CUSTOMER HAD PROGRAMMED A BOLUS OF 10 UNITES AND SAW THE DEVICE DELIVERY SOME OF THE BOLUS BUT THEN THE SCREEN SHOWED 0, AND NOW SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE. UPON TROUBLESHOOTING, IT WAS FOUND THAT INSULIN DID EXIT FROM THE TUBING DURING A MANUAL PRIME AND NO LEAK WAS NOTED. THE DEVICE PASSED THE HIGH PRESSURE TEST; ADVISED THE CUSTOMER THAT THE INSULIN PUMP WAS WORKING AS DESIGNED. ADVISED THE CALLER NOT TO HAVE THE CUSTOMER PREFILL RESERVOIRS. FOUND THE CUSTOMER HAD DELIVERED A DUAL WAVE BONUS WHEN SHE HAD NO IDEA OF ITS FUNCTION. ADVISED REPLACEMENT OF THE INFUSION SETS AND BROKEN BELT CLIP. NOTHING FURTHER REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431357 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization