BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3864553 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-02967
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    CUSTOMER'S WIFE REPORTED THAT HER HUSBAND WAS HOSPITALIZED DUE TO CONGESTIVE HEART FAILURE AND PNEUMONIA. SHE ALSO REPORTED THAT THE INSULIN PUMP WAS SHOWING BAD READINGS. CALLER STATED THAT THE NURSES FELT THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN TO HIS BODY. THE CUSTOMER'S BLOOD GLUCOSE WAS 359 MG/DL WITH REPORTED SYMPTOMS OF FATIGUE AND CRANKINESS. THE CUSTOMER WAS TREATED FOR HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341432 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization