BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3173982 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94798
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    August 23, 2012
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 HAVING UNEXPLAINED HIGH BLOOD GLUCOSE OF 436MG/DLK. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTING WERE CORRECT. THE CUSTOMER DID NOT HAVE EXTRA SUPPLIES TO CONTINUE TESTING. A FOLLOW UP WAS CONDUCTED, AND FOUND THAT THE CUSTOMER HAD CALLED TO THE PARAMEDICS SEVERAL TIMES DUE TO LOW BLOOD GLUCOSE WITHIN THE LAST MONTH. THE CUSTOMER STATED THAT HE IS SURE THE INSULIN PUMP IS FUNCTIONING PROPERLY AND FURTHER TESTING WAS DECLINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274027 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention