BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3831149 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84934
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND STATED HIS WIFE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE, PNEUMONIA, AN INFECTION AND A HEART ATTACK. THE CUSTOMER WAS HOSPITALIZED FROM (B)(6) 2014 TO (B)(6) 2014. THE BLOOD GLUCOSE READING WAS OVER 600 AT THE TIME OF HOSPITALIZATION. ON (B)(6) 2014, THE CUSTOMER SAID HE WAS HAVING TROUBLE REWINDING AND PRIMING THE INFUSION SET. THE CUSTOMER WAS ASSISTED WITH THE REWIND AND PRIME SET UP PROCESS FOR THE INFUSION SET. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308681 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization