BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984022 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91427
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 500MG/DL. THE CUSTOMER STATED THAT SHE HAS BEEN CONNECTED TO THE INSULIN PUMP SINCE SHE SOUGHT MEDICAL ATTENTION AND THEY CHANGED THE SITE, AND HER GLUCOSE LEVEL DROPPED TO 170MG/DL. ASSISTED THE CUSTOMER TO RUN THE DISPLACEMENT, FIXED PRIME, AND MANUAL PRIME, BUT THE HIGH PRESSURE TEST WAS NOT PERFORMED AS CUSTOMER DID NOT HAVE A TUBING CLAMP AVAILABLE AT THE TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86117 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization