BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3864589 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-85370
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    NURSE REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER IS HOT, THIRSTY, DRY MOUTH, NAUSEATED AND VOMITING. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 493 MG/DL. HOSPITAL TREATED WITH IV. DURING TROUBLESHOOTING, THE TIME AND DATE ARE INCORRECT. ASSISTED CUSTOMER WITH CORRECTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340947 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 21 YR Hospitalization