BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2962652 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-91049
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 1, 2013
    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 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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN URGENT CARE VISIT WITH HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER WAS FEELING MORE LETHARGIC AND HER BODY FEELS DRY DUE TO AN INCREASE IN THIRST AND URINATION. TROUBLESHOOTING WAS PERFORMED. THE NURSE STATED THAT THE CUSTOMER HAD EAR ACHE CAUSED BY THE HIGH BLOOD GLUCOSE. THE CALLER MENTIONED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR A FEW WEEKS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64754 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization